PMA Final Decisions Rendered for January 1998

Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for January 1998. This list is generated on a monthly basis.

PMA Original Approvals

APPLICATION NUMBER/ DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION/ INDICATIONS
P970012 1/30/98	Medtronic.Kappa 400 Series Pacemakers, which includes; Medtronic.Kappa KDR 401/403 & KSR 401/403 Implantable Pulse Generators with Medtronic.Vision (Model 9952E) Software, and Medtronic Model 9462 Remote Assistant.	Medtronic, Inc. Minneapolis, MN 55432	These devices are indicated for the following: 1)Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity and/or minute ventilation; 2)Accepted patient conditions warranting chronic cardiac pacing which include: a)symptomatic paroxysmal or permanent 2nd or 3rd degree AV block; b) symptomatic bilateral bundle branch block; c) symptomatic paroxysmal or transient sinus node dysfunction's with or without associated AV conduction disorders; d) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and e) vasovagal syndromes or hypersensitive carotid sinus syndromes. 3) Medtronic.Kappa 400 Series Pacemakers are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate & AV synchrony, which include: a) various degrees of AV block to maintain the atrial contribution to cardiac output; and b) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.
P960030 1/29/98	Passive Plus® DX Endocardial, Steroid Eluting Pacing Leads Models 1342T, 1343K, 1346T, and 1345K	Pacesetter, Inc. Sylmar, CA 91342	Approval for the Passive Plus® DX Endocardial, Steroid Eluting, Passive- Fixation Pacing Leads, Models 1342T, 1343K, 1346T, and 1345K. This device is indicated for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium (Models 1342T or 1343K) or ventricle (Models 1345K or 1346T).

APPLICATION NUMBER/
DATE of APPROVAL

DEVICE
TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION/ INDICATIONS

P970012

1/30/98

Medtronic.Kappa 400 Series Pacemakers, which includes; Medtronic.Kappa KDR 401/403 & KSR 401/403 Implantable Pulse Generators with Medtronic.Vision (Model 9952E) Software, and Medtronic Model 9462 Remote Assistant.

Medtronic, Inc.

Minneapolis, MN

55432

These devices are indicated for the following: 1)Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity and/or minute ventilation; 2)Accepted patient conditions warranting chronic cardiac pacing which include: a)symptomatic paroxysmal or permanent 2nd or 3rd degree AV block; b) symptomatic bilateral bundle branch block; c) symptomatic paroxysmal or transient sinus node dysfunction's with or without associated AV conduction disorders; d) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and e) vasovagal syndromes or hypersensitive carotid sinus syndromes. 3) Medtronic.Kappa 400 Series Pacemakers are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate & AV synchrony, which include: a) various degrees of AV block to maintain the atrial contribution to cardiac output; and b) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.

P960030

1/29/98

Passive Plus® DX Endocardial, Steroid Eluting Pacing Leads Models 1342T, 1343K, 1346T, and 1345K

Pacesetter, Inc.

Sylmar, CA

91342

Approval for the Passive Plus® DX Endocardial, Steroid Eluting, Passive- Fixation Pacing Leads, Models 1342T, 1343K, 1346T, and 1345K. This device is indicated for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium (Models 1342T or 1343K) or ventricle (Models 1345K or 1346T).

PMA SUPPLEMENTAL APPROVALS
APPLICATION NUMBER/ DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION/ INDICATIONS
P810046/S182 1/27/98	ACS RX ESPRIT™ PTCA Catheter	Guidant Vascular Intervention Temecula,CA 92591-4628	Approval for an E-beam sterilization process validation protocol and a manufacturing site located at Guidant Corporation, Advanced Cardiovascular Systems, 26531 Ynez Rd., Temecula, CA 92591-4628.
P830056/S078 1/29/98	Ultraviolet-Absorbing Posterior Chamber Intraocular Lenses Models C440Z, U211M, UV91F, UV91F2, U691F, U691F2, C440U, C421F5, and C451F5.	Mentor Corporation Santa Barbara, CA 93111	Approval for lenses Models C440Z, U211M, UV91F, UV91F2, U691F, U691F2, C440U, C421F5, and C451F5. These lenses are intended to be used for primary implantation for the visual correction of aphakia in patients 50 years of age or older where a cataractous lens has been removed using extracapsular extraction methods. The lenses are intended to be placed in either the ciliary sulcus or capsular bag.
P840001/S041 1/20/98	Itrel Spinal Cord Stimulation System	Medtronic Neurological Minneapolis, MN 55440-9087	Approval for the use of an alternative packaging material, uncoated PETG (polyethylene terephthalate, glycol modified) for the manufacture of the inner and outer packaging trays. The device, as modified, will be marketed under the trade name Itrel and is indicated for Spinal Cord Stimulation.
P840024/S073 1/12/98	Nucleus 22 Channel Cochlear Implant	Cochlear Corporation Englewood, CO 80112	Approval to modify the locating tabs on the battery lids of the Mini Speech Processor case and the Spectra Speech Processor case.
P860005/S010 1/8/98	Pro Osteon® Implant 500 Porous Coralline Hydroxyapatite Bone void Filler Blocks and Granules	Interpore International Irvine, CA 92618-2402	Approval for a change to the name of the product from "Bone Void Filler" to "Bone Graft Substitute." The device, as modified in designation, will be marketed under the trade name "Pro Osteon Implant 500 Porous Coralline Hydroxyapatite Bone Graft Substitute Blocks and Granules," and is indicated for the same indications approved in the original PMA and in P860006/S002.
P860064/S009 1/26/98*	DuPen Long term Epidural Catheter and Repair Kits	C.R. Bard, Inc. Salt Lake City, UT	Approval for modifications to the instructions for use (IFU) for the DuPen Long Term Epidural Catheter and the DuPen Catheter Repair Kit. These six modifications are: 1) to delete references to resterilization of product; 2) to add a caution to the Repair Kit IFU to examine the package and not use or resterilize if package is damaged; 3) to add the prescription statement to the Repair Kit IFU; 4) To add international units of measure and general international requirements; 5) To add a general biohazard statement concerning handling of product after use to the IFUs and product labels; and 6) to add an international symbol (explained in the device IFU) to the external catheter sleeve "Attention, See Instructions for Use."
P870072/S006 1/21/98	Thoratec Ventricular Assist Device (VAD) System	Thoratec Laboratories Corporation Pleasanton, CA 94588	Approval for 1) changing the thread sealant/thread locking material for the stainless steel pneumatic driveline fitting to the polysulfone VAD case cap from room temperature vulcanizing (RTV) silicone to Master Bond Polymer System EP21LV, and 2) replacing the current two-piece welded hand pump bulb with a single-piece molded bulb.
P890003/S052 1/29/98	Model 9802E Reveal™ Insertable Loop Recorder Software	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for the Model 9802E Reveal™ Insertable Loop Recorder Software for use with the Model 9790/9790C Programmers.
P890027/S042 1/12/98	Nucleus 22 Channel Cochlear Implant	Cochlear Corporation Englewood, CO 80112	Approval to modify the locating tabs on the battery lids of the Mini Speech Processor case and the Spectra Speech Processor case.
P910016/S009 1/15/98*	Unicompartmental Configuration of the new jersey LCS® Total Knee System	DePuy, Inc. Warsaw, IN 46581-0988	Approval for a change to the name of the Unicompartmental Configuration of the new jersey LCS® Total Knee System. This device will now be marketed under the trade name Unicompartmental Configuration of the LCS® Total Knee System and is indicated for uncemented use in patients over 60 years old undergoing unicompartmental knee surgery for rehabilitating knees when only one condyle has been damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis or post-traumatic arthritis.
P910016/S010 1/15/98*	Unicompartmental Configuration of the LCS® Total Knee System	DePuy, Inc. Warsaw, IN 46581-0988	Approval for the use of multilingual package labeling and a multilingual package insert for the components of the Unicompartmental Configuration of the LCS® Total Knee System.
P910019/S003 1/29/98	TEC® Coronary Atherectomy System	InterVentional Technologies, Inc. San Diego, CA 92123	Approval for a change to the 5.5F TEC® cutter catheter, involving an increase in the skirt length of the cutter component from 0.079 inches to 0.104 inches.
P910020/S020 1/30/98*	Edgeband Pacers and Alternate PETG Packaging	Sulzer Intermedics, Inc. Angleton, TX 77515	Approval for the Edgeband Design on the Marathon SR Model 292-09, Relay Model 293-03, Marathon DR Model 293-09, Marathon DR Model 294-09, and Momentum DR Model 294-23. The devices, as modified, will be marketed under the trade name Edgeband pacemakers, with the following models: Marathon SR Model 292-09E, Relay Model 293-03E, Marathone DR Model 293-09E, Marathon DR Model 294-09E, and Momentum DR Model 294-23E. The supplement also requested approval for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all Edgeband and all Side-Lock™ pulse generator models.
P910077/S022 1/23/98	VENTAK® MINI™ AICD™ Systems, VENTAK® MINI™ HE, and VENTAK® MINI™ III	Guidant Corporation Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798	Approval for higher shock energy for the VENTAK MINI HE, the downsized VENTAK MINI III, revisions to the VENTAK MINI Application Software-Model 2840, and labeling revisions to indicate shock energy as joules "stored" and updating the indications for use.
P930016/S005 1/29/98	VISX Excimer Laser System Models "B" and "C" for Photorefractive Keratectomy (PRK) for High Myopia with and without Astigmatism. Indicated for myopic & astigmatic PRK using an ablation zone with a 6.0 mm major axis.	VISX, Inc. Santa Clara, CA 95051	Intended for use: 1) in patients with documented evidence of a change in manifest refraction of less than or equal to 0.5D (in both cylinder & sphere components) per yr for at least one yr. prior to the date of the pre-operative examination; and 2) in patients 18-20 yrs of age in PRK treatments for the reduction or elimination of myopia (nearsightedness) of less than or equal to -6.0D spherical equivalent at the corneal plane with less than or equal to -1.0D of astigmatism; or 3)in patients 21yrs of age or older in PRK treatments for the reduction or elimination of myopia (nearsightedness) of between 0 and -12.0D spherical myopia at the spectacle plane and up to -4.0D of astigmatism.
P940010/S002 1/9/98	OPTIGUIDE Fiber Optic Diffuser DCYL Series	QLT Phototherapeutics, Inc. Washington,DC 20004-1109	Approval for the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated and approval to add a 2.0 cm diffuser to the DCYL Series of diffusers.
P940011/S001 1/9/98	Coherent Lambda Plus PDL1 and PDL2 Photodynamic Lasers	Coherent Medical Group Palo Alto, CA 94303	Approval for the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated.
P940012/S001 1/9/98	Series 600 Dye Laser Modules (operating at 630 +/- nm) and Series 800 KTP/532 and KTP/YAG (operating at 532 nm) Surgical Lasers	Laserscope San Jose, CA 95134-2011	Approval for the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer patients for whom surgery and radiotherapy are not indicated.
P940034/S005 1/7/98	Gen-Probe Amplified Mycobacterium Tuberculosis Direct (MTD) Test	Gen-Probe, Inc. San Diego, CA 92121	Approval for Physician Prescribing Information to be considered a component of the labeling for MTD. At this time there are no provisions for "in vitro" device labeling other than prescribed 21 CFR 809.10 (b); however, the Physician Prescribing Information may be used as promotional and advertising material.
P950014/S012 1/22/98*	Prostatron Maxis	EDAP Technomed, Inc. Burlington, MA 01803	Approval for a new trade name for the single-module configuration of the Prostatron. The device will be marketed under the trade name Prostatron Maxis and is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH).
P960001/S003 1/27/98*	DePuy 1 Bone Cement	DePuy, Inc. Warsaw, IN 46581-0988	Approval for the following changes: 1) to remove ascorbic acid and ethanol from the liquid monomer formulation; and 2) omit the quality control test for dimensional change from the finished product specification.
P970003/S004 1/29/98	NeuroCybernetic Prosthesis (NCP®) System	Cyberonics, Inc. Webster, TX 77598-4135	Approval for NCP® Model 100C Pulse Generator with modifications to the microcontroller and battery. The device, as modified, will be marketed under the trade name NCP® Model 100C Pulse Generator and is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures which are refractory to anti-epileptic medications.
P970008/S002 1/9/98	Targis System	Urologix Minneapolis, MN 55447	Approval for a new manufacturing facility located at SeaMED Corp., 21621 30^th Ave., NE, Bothell, WA 98021.

PMA SUPPLEMENTAL APPROVALS

APPLICATION NUMBER/
DATE of APPROVAL

DEVICE
TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION/ INDICATIONS

P810046/S182

1/27/98

ACS RX ESPRIT™ PTCA Catheter

Guidant Vascular Intervention

Temecula,CA

92591-4628

Approval for an E-beam sterilization process validation protocol and a manufacturing site located at Guidant Corporation, Advanced Cardiovascular Systems, 26531 Ynez Rd., Temecula, CA 92591-4628.

P830056/S078

1/29/98

Ultraviolet-Absorbing Posterior Chamber Intraocular Lenses Models C440Z, U211M, UV91F, UV91F2, U691F, U691F2, C440U, C421F5, and C451F5.

Mentor Corporation

Santa Barbara, CA 93111

Approval for lenses Models C440Z, U211M, UV91F, UV91F2, U691F, U691F2, C440U, C421F5, and C451F5. These lenses are intended to be used for primary implantation for the visual correction of aphakia in patients 50 years of age or older where a cataractous lens has been removed using extracapsular extraction methods. The lenses are intended to be placed in either the ciliary sulcus or capsular bag.

P840001/S041

1/20/98

Itrel Spinal Cord Stimulation System

Medtronic Neurological

Minneapolis, MN

55440-9087

Approval for the use of an alternative packaging material, uncoated PETG (polyethylene terephthalate, glycol modified) for the manufacture of the inner and outer packaging trays. The device, as modified, will be marketed under the trade name Itrel and is indicated for Spinal Cord Stimulation.

P840024/S073

1/12/98

Nucleus 22 Channel Cochlear Implant

Cochlear Corporation

Englewood, CO

80112

Approval to modify the locating tabs on the battery lids of the Mini Speech Processor case and the Spectra Speech Processor case.

P860005/S010

1/8/98

Pro Osteon® Implant 500 Porous Coralline Hydroxyapatite Bone void Filler Blocks and Granules

Interpore International

Irvine, CA

92618-2402

Approval for a change to the name of the product from "Bone Void Filler" to "Bone Graft Substitute." The device, as modified in designation, will be marketed under the trade name "Pro Osteon Implant 500 Porous Coralline Hydroxyapatite Bone Graft Substitute Blocks and Granules," and is indicated for the same indications approved in the original PMA and in P860006/S002.

*P860064/S009

1/26/98

DuPen Long term Epidural Catheter and Repair Kits

C.R. Bard, Inc.

Salt Lake City, UT

Approval for modifications to the instructions for use (IFU) for the DuPen Long Term Epidural Catheter and the DuPen Catheter Repair Kit. These six modifications are: 1) to delete references to resterilization of product; 2) to add a caution to the Repair Kit IFU to examine the package and not use or resterilize if package is damaged; 3) to add the prescription statement to the Repair Kit IFU; 4) To add international units of measure and general international requirements; 5) To add a general biohazard statement concerning handling of product after use to the IFUs and product labels; and 6) to add an international symbol (explained in the device IFU) to the external catheter sleeve "Attention, See Instructions for Use."

P870072/S006

1/21/98

Thoratec Ventricular Assist Device (VAD) System

Thoratec Laboratories Corporation

Pleasanton, CA

94588

Approval for 1) changing the thread sealant/thread locking material for the stainless steel pneumatic driveline fitting to the polysulfone VAD case cap from room temperature vulcanizing (RTV) silicone to Master Bond Polymer System EP21LV, and 2) replacing the current two-piece welded hand pump bulb with a single-piece molded bulb.

P890003/S052

1/29/98

Model 9802E Reveal™ Insertable Loop Recorder Software

Medtronic, Inc.

Minneapolis, MN

55432-3576

Approval for the Model 9802E Reveal™ Insertable Loop Recorder Software for use with the Model 9790/9790C Programmers.

P890027/S042

1/12/98

Nucleus 22 Channel Cochlear Implant

Cochlear Corporation

Englewood, CO

80112

Approval to modify the locating tabs on the battery lids of the Mini Speech Processor case and the Spectra Speech Processor case.

*P910016/S009

1/15/98

Unicompartmental Configuration of the new jersey LCS® Total Knee System

DePuy, Inc.

Warsaw, IN

46581-0988

Approval for a change to the name of the Unicompartmental Configuration of the new jersey LCS® Total Knee System. This device will now be marketed under the trade name Unicompartmental Configuration of the LCS® Total Knee System and is indicated for uncemented use in patients over 60 years old undergoing unicompartmental knee surgery for rehabilitating knees when only one condyle has been damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis or post-traumatic arthritis.

*P910016/S010

1/15/98

Unicompartmental Configuration of the LCS® Total Knee System

DePuy, Inc.

Warsaw, IN

46581-0988

Approval for the use of multilingual package labeling and a multilingual package insert for the components of the Unicompartmental Configuration of the LCS® Total Knee System.

P910019/S003

1/29/98

TEC® Coronary Atherectomy System

InterVentional Technologies, Inc.

San Diego, CA

92123

Approval for a change to the 5.5F TEC® cutter catheter, involving an increase in the skirt length of the cutter component from 0.079 inches to 0.104 inches.

*P910020/S020

1/30/98

Edgeband Pacers and Alternate PETG Packaging

Sulzer Intermedics, Inc.

Angleton, TX

77515

Approval for the Edgeband Design on the Marathon SR Model 292-09, Relay Model 293-03, Marathon DR Model 293-09, Marathon DR Model 294-09, and Momentum DR Model 294-23. The devices, as modified, will be marketed under the trade name Edgeband pacemakers, with the following models: Marathon SR Model 292-09E, Relay Model 293-03E, Marathone DR Model 293-09E, Marathon DR Model 294-09E, and Momentum DR Model 294-23E. The supplement also requested approval for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all Edgeband and all Side-Lock™ pulse generator models.

P910077/S022

1/23/98

VENTAK® MINI™ AICD™ Systems, VENTAK® MINI™ HE, and VENTAK® MINI™ III

Guidant Corporation Cardiac Pacemakers (CPI)

St. Paul, MN

55112-5798

Approval for higher shock energy for the VENTAK MINI HE, the downsized VENTAK MINI III, revisions to the VENTAK MINI Application Software-Model 2840, and labeling revisions to indicate shock energy as joules "stored" and updating the indications for use.

P930016/S005

1/29/98

VISX Excimer Laser System Models "B" and "C" for Photorefractive Keratectomy (PRK) for High Myopia with and without Astigmatism. Indicated for myopic & astigmatic PRK using an ablation zone with a 6.0 mm major axis.

VISX, Inc.

Santa Clara, CA

95051

Intended for use:

1) in patients with documented evidence of a change in manifest refraction of less than or equal to 0.5D (in both cylinder & sphere components) per yr for at least one yr. prior to the date of the pre-operative examination; and 2) in patients 18-20 yrs of age in PRK treatments for the reduction or elimination of myopia (nearsightedness) of less than or equal to -6.0D spherical equivalent at the corneal plane with less than or equal to -1.0D of astigmatism; or 3)in patients 21yrs of age or older in PRK treatments for the reduction or elimination of myopia (nearsightedness) of between 0 and -12.0D spherical myopia at the spectacle plane and up to -4.0D of astigmatism.

P940010/S002

1/9/98

OPTIGUIDE Fiber Optic Diffuser DCYL Series

QLT Phototherapeutics, Inc.

Washington,DC

20004-1109

Approval for the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated and approval to add a 2.0 cm diffuser to the DCYL Series of diffusers.

P940011/S001

1/9/98

Coherent Lambda Plus PDL1 and PDL2 Photodynamic Lasers

Coherent Medical Group

Palo Alto, CA

94303

Approval for the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated.

P940012/S001

1/9/98

Series 600 Dye Laser Modules (operating at 630 +/- nm) and Series 800 KTP/532 and KTP/YAG (operating at 532 nm) Surgical Lasers

Laserscope

San Jose, CA

95134-2011

Approval for the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer patients for whom surgery and radiotherapy are not indicated.

P940034/S005

1/7/98

Gen-Probe Amplified Mycobacterium Tuberculosis Direct (MTD) Test

Gen-Probe, Inc.

San Diego, CA

92121

Approval for Physician Prescribing Information to be considered a component of the labeling for MTD. At this time there are no provisions for "in vitro" device labeling other than prescribed 21 CFR 809.10 (b); however, the Physician Prescribing Information may be used as promotional and advertising material.

*P950014/S012

1/22/98

Prostatron Maxis

EDAP Technomed, Inc.

Burlington, MA

01803

Approval for a new trade name for the single-module configuration of the Prostatron. The device will be marketed under the trade name Prostatron Maxis and is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH).

*P960001/S003

1/27/98

DePuy 1 Bone Cement

DePuy, Inc.

Warsaw, IN

46581-0988

Approval for the following changes: 1) to remove ascorbic acid and ethanol from the liquid monomer formulation; and 2) omit the quality control test for dimensional change from the finished product specification.

P970003/S004

1/29/98

NeuroCybernetic Prosthesis (NCP®) System

Cyberonics, Inc.

Webster, TX

77598-4135

Approval for NCP® Model 100C Pulse Generator with modifications to the microcontroller and battery. The device, as modified, will be marketed under the trade name NCP® Model 100C Pulse Generator and is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures which are refractory to anti-epileptic medications.

P970008/S002

1/9/98

Targis System

Urologix

Minneapolis, MN

55447

Approval for a new manufacturing facility located at SeaMED Corp., 21621 30^th Ave., NE, Bothell, WA 98021.

Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 23

Summary of PMA Originals Under Review
Total Under Review: 78
Total Active: 33
Total On Hold: 45
Number Greater Than 180 Days: 5

Summary of PMA Supplements Under Review
Total Under Review: 201
Total Active: 115
Total On Hold: 80
Number Greater Than 180 Days: 8

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 23
Average Days Fr Filing to Decision (Total Elapsed Time): 139.6
Average Days Fr Filing to Decision (FDA Elapsed Time): 93.8
Average Days Fr Filing to Decision (Applicant Elapsed Time): 45.7
Number Greater Than 180 Days (Overdue): 3

Summary of PMA Originals & Supplements Approved
Originals: 8
Supplements: 100

Summary of PMA Originals Under Review
Total Under Review: 79
Total Active: 36
Total On Hold: 43
Number Greater Than 180 Days: 2

Summary of PMA Supplements Under Review
Total Under Review: 197
Total Active: 102
Total On Hold: 84
Number Greater Than 180 Days: 6

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 100
Average Days Fr Filing to Decision (Total Elapsed Time): 127.4
Average Days Fr Filing to Decision (FDA Elapsed Time): 74.1
Average Days Fr Filing to Decision (Applicant Elapsed Time): 16.1
Number Greater Than 180 Days (Overdue): 8