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PMA SUPPLEMENTAL APPROVALS
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APPLICATION NUMBER / DATE of APPROVAL
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DEVICE TRADE NAME
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COMPANY NAME
CITY, STATE, & ZIP
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DEVICE DESCRIPTION / INDICATIONS
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N18033/S035
4/12/01
180-Day
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ACUVUE® 2 COLOURS Brand (etafilcon A) Soft (hydrophilic) Contact
Lens with UV Blocker
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Vistakon, Division of Johnson & Johnson Vision Care, Inc.
Jacksonville, FL
32216
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Approval for etafilcon A soft (hydrophilic) contact lens for extended
wear with UV blocker and the following listed color additives: iron oxide
black, iron oxide brown, iron oxide red, iron oxide yellow, titanium dioxide,
phthalocyaninato (2-) copper, phthalocyanine green and vat orange 1. The
device will be marketed with the following trade names and indications:
The ACUVUE® 2 COLOURS Contact Lenses are indicated for daily wear
to enhance or alter the apparent color of the eye and/or for the correction
of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic
persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) BIFOCAL Contact
Lens is indicated for daily wear for the correction of distance and near
vision in presbyopic, aphakic or non-aphakic persons with non-diseased
eyes who may have 0.75D of astigmatism or less. The ACUVUE® 2 COLOURS
(etafilcon A) Soft (hydrophilic) TORIC Contact Lens is indicated for daily
wear for the correction of visual acuity in aphakic or non-aphakic persons
with non-diseased eyes that are hyperopic or myopic and may have 10.00D
of astigmatism or less. The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic)
TORIC-BIFOCAL Contact Lens is indicated for daily wear for the correction
of distance and near vision in presbyopic aphakic or non-aphakic persons
with non-diseased eyes who may have 10.00D of astigmatism or less. ACUVUE®
2 COLOURS UV Blocking Contact Lenses help protect against transmission
of harmful UV radiation to the cornea and into the eye. The ACUVUE®
2 COLOURS Contact Lenses may be prescribed for daily wear. Eye Care Practitioners
may prescribe the lenses either for single-use disposable wear or frequent/planned
replacement wear with cleaning, disinfection and scheduled replacement
(see "Wearing Schedule.") When prescribed for frequent/planned
replacement wear, the lenses may be disinfected using a chemical disinfection
system only.
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P830055/S075
4/17/01
180-Day
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LCS® Total Knee System
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DePuy Orthopaedics, Inc
Warsaw, IN
46581
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Approval for a manufacturing site located at Cycam, Inc., Houston, Pennsylvania.
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P840068/S041
4/30/01
Real-Time
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Vigor Model 2880 v5.2 Software
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Guidant Corporation
St. Paul, MN
55112
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Approval for the Vigor Model 2880 v5.2 Software.
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P850051/S056
4/18/01
Real-Time
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Premier Pacing System
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Medtronic, Inc.
Shoreview, MN
55126
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Approval for the Premier Pacing System, including the Premier Model 8081
VVI Pacemaker, the CapSure Model 4003M Endocardial Lead and the Model
9884 Software for the Model 9790 and 9790C Programmers.
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P890043/S035
4/6/01
180-Day
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FLEXI-CUT™ Direction Debulking System
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Guidant Corporation
Temecula, CA
92589
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Approval for the FLEXI-CUT™ Direction Debulking System. The FLEXI-CUT™
Direction Debulking System is indicated for use in coronary artery disease
accessible to DCA (Directional Coronary Atherectomy), generally in the
proximal or mid-portion of coronary vessels. It can be used alone or in
conjunction with other coronary interventional devices. DCA is intended
to improve coronary luminal diameter by mechanically shaving and removing
atherosclerotic material from the diseased vessel.
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P890055/S012
4/24/01
Real-Time
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Device: Arrow OR Pump Heater & AP-07009 Flex Tip Plus Intraspinal
Kit
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Arrow International
Walpole, MA
02081
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Approval for the addition of: 1) an OR Pump Heater (AP-09100) and Drape
(AP-09150) as an option to the traditional water bath; 2) a Micropipette
OR Prep Kit (AP-07004) for the measurement of flow from the implantable
pump prior to implantation; and 3) accessories to the Intraspinal Kit
(AP-07009), including an additional needle and both winged and traditional
catheter anchors.
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P900033/S005
4/30/01
Real-Time
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INTEGRA® Artificial Skin, Dermal Regeneration Template
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Integra LifeSciences Corporation
Plainsboro, NJ
08536
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Approval for a change in the trade name. The device will be marketed
under the trade name INTEGRA® Dermal Regeneration Template and is
indicated for the post-excisional treatment of life-threatening full-thickness
or deep partial-thickness thermal injury where sufficient autograft is
not available at the time of excision or not desirable due to the physiological
condition of the patient.
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P900043/S026
4/6/01
Real-Time
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Bx VELOCITY™ Stent on
RaptorRail™ Stent Delivery System (RX)
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Cordis Corporation
Warren, NJ
07059
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Approval for a modified stent/delivery system. The device, as modified,
will be marketed under the trade name Bx VELOCITY™ Stent on RaptorRail™
Stent Delivery System (RX) and is indicated for improving coronary luminal
diameter in the treatment of abrupt or threatened vessel closure in patients
with failed interventional therapy in lesions (£
30 mm in length) with reference diameters in the range of 2.25 mm to 4.00
mm.
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P900056/S062
4/17/01
180-Day
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Rotablator® Rotational Angioplasty System Guide Wires
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Boston Scientific Corporation
Redmond, WA
98052
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Approval for an additional manufacturing site located at Boston Scientific
Miami Technology Center (BSMTC), Miami, Florida.
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P910068/S001
4/4/01
180-Day
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Vitreon® Intraocular Fluid (Perfluoroperhydrophenanthrene)
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Vitrophage, Inc.
Lyons, IL
60534
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Approval for 1) manufacturing site change: the new site for manufacturing
the bulk medical grade Perfluoroperhydrophenanthrene (APF-215M) will be
at FluoroMed, L.P. (FMLP), Round Rock, Texas; 2) manufacturing change:
APF-215M will me manufactured from perfluoroperhydrophenanthrene raw material
instead of from phenanthrene raw material; and 3) APF-215M specification
change regarding testing parameter for lower boiling components.
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P920032/S006
4/6/01
180-Day
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Model 4553 and 4570 MICRO-PACE Dual Chamber, DDD, Temporary Cardiac Pacemakers
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PACE Medical, Inc.
Waltham, MA
02451
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Approval to modify the temporary pacemakers by replacing the zener diodes
used for protecting the internal electronics from high voltage transients
with a transient voltage suppressor.
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P930016/S012
4/27/01
Panel Track
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VISX STAR S2 and S3 Excimer Laser Systems
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VISX, Inc.
Santa Clara, CA
95051
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Approval for the VISX STAR S2 and S3 Excimer Laser Systems. The devices
are indicated for laser in-situ keratomileusis (LASIK) treatments: 1)
in patients with documented evidence of a change in manifest refraction
of no more than 0.5 D (in both cylinder and sphere components) for at
least one year prior to the date of pre-operative examination; and 2)
in patients 21 years of age or older in treatments for the reduction of
elimination of naturally occurring hyperopia between +05 and +5.0 D sphere
at the spectacle plane with or without refractive astigmatism up to +3.0
D, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0
D.
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P940007/S006
4/2/01
180-Day
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Silicone Posterior Chamber Intraocular Lens, Model 912
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Pharmacia & Upjohn Company
Pickerington, OH
43147
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Approval for sterilizing the silicone posterior chamber intraocular lens,
Model 912, at the facility in Groningen, The Netherlands and for changes
in the sterilization cycle parameters for Model 912 from 100% ethylene
oxide (EtO) to 20 % EtO/80% carbon dioxide.
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P940008/S016
4/25/01
Special
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Intermedics MICRON ICD Models 101-05, 101-05ST, 101-09, 101-09ST, 101-10
and 101-10A
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Guidant Corporation
St. Paul, MN
55112
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Approval for labeling changes to the follow-up indicators reflecting
battery longevity.
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P940031/S026
4/30/01
Real-Time
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Vigor Model 2880 v5.2 Software
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Guidant Corporation
St. Paul, MN
55112
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Approval for the Vigor Model 2880 v5.2 Software.
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P950002/S009
4/3/01
Special
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BAK Interbody Fusion System
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Sulzer Spine-Tech
Minneapolis, MN
55439
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Approval for a change to the labeling of the BAK Interbody Fusion System
adding a precaution statement (i.e., The BAK/Proximity device is to be
used only in conjunction with a standard BAK device. The safety and effectiveness
of the BAK/Proximity device has not been established when used otherwise.)
effective April 1, 2001.
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P950032/S022
4/26/01
180-Day
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Apligraf (Graftskin)
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Organogenesis, Inc.
Canton, MA
02021
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Approval for replacement of the soybean trypsin inhibitor reagent in
Apligraf manufacture with the newly defined trypsin quenching medium.
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P960004/S018
4/6/01
Real-Time
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ThinLine II/ FINELINE II and ThinLine II/ FINELINE II Sterox Active-Fixation
Endocardial Pacing Leads
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Guidant Corporation
St. Paul, MN
55112
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Approval for the use of mannitol as an alternate material to cover the
helix on the above referenced active fixation pacing leads. These devices
are indicated for permanent pacing and sensing of the atrium and/or ventricle
when used with a compatible pulse generator.
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P960028/S006
4/25/01
180-Day
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ARRAY® Multifocal UV-Absorbing Silicone Posterior Chamber Intraocular
Lens (IOL) – Models SA40N2 and SA40e
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Allergan, Inc.
Irvine, CA
92612
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Approval for the SA40N2 and SA40e lens models.
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P960040/S021
4/5/01
Real-Time
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VENTAK® PRIZM™ Model 2844 Software Application, Version 3.3
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Guidant Corporation
St. Paul, MN
55112
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Approval for VENTAK® PRIZM™ Model 2844 Software Application,
Version 3.3.
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P960052/S002
4/4/01
Special
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DERMABOND® Topical Skin Adhesive (2-octyl cyanoacrylate)
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Closure Medical Corporation
Raleigh, NC
27616
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Approval to modify the labeling in order to clarify the instructions
for preparing and storing the device.
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D970012/S005
4/25/01
180-Day
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AMS 700 Series Product Line Inflatable Penile Prostheses with InhibiZone™
Antibiotic Surface Treatment
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American Medical Systems, Inc.
Minnetonka, MN
55343
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Approval for the addition of an antibiotic surface treatment to the CX,
CX Preconnect, CXM, and Ultrex models of the AMS 700 Series Product Line
Inflatable Penile Prostheses. The modified device will be sold under the
tradename AMS 700 Series Product Line Inflatable Penile Prostheses with
InhibiZone™ Antibiotic Surface Treatment.
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P970013/S001
4/30/01
180-Day
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Microny II SR+ Model 2525T and Microny K SR Model 2535K Pulse Generators
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St. Jude Medical, Inc.
Sylmar, CA
91342
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Approval for the Microny II SR+ Model 2525T and Microny K SR Model 2535K
Pulse Generators.
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P970035/S022
4/4/01
180-Day
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S7 with Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary
Stent Systems
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Medtronic AVE, Inc.
Santa Rosa, CA
95403
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Approval for the S7 with Discrete Technology™ Over-the-Wire (OTW)
and Rapid Exchange (RX) Coronary Stent Systems. The devices are indicated
for improving coronary luminal diameter in patientss with symptomatic
ischemic heart disease due to de novo lesions (length £
30 mm) in native coronary arteries with reference vessel diameters ranging
from 3.0 mm and 4.0 mm. Long term outcome (beyond 14 days) for this permanent
implant is unknown at present. The RX delivery system will allow for perfusion
at an average rate of 2 cc/minute at nominal pressure during the 15-30
second stent deployment procedure only. The rapid exchange stent delivery
system is not intended for use as a stand alone PTCA perfusion catheter.
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P980040/S001
4/18/01
180-Day
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SENSAR® Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular
Lens (IOL)
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Allergan, Inc.
Irvine, CA
92623
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Approval for the acrylic sheet casting and button fabrication manufacturing
processes to be performed at A.M.O. Puerto Rico, Inc., Anasco, Puerto
Rico.
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P980050/S001
4/6/01
Panel Track
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Medtronic® Model 7250 Jewel® AF Implantable Cardioverter Defibrillator
System Medtronic Model 9465 InCheck™ Patient Assistant and Medtronic
Transvene® CS/SVC Model 6937 A Lead
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Medtronic, Inc.
Shoreview, MN
55126
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Approval for the Medtronic® Model 7250 Jewel® AF Implantable
Cardioverter Defibrillator System, Medtronic Model 9465 InCheck™
Patient Assistant and the Medtronic Transvene® CA/SVC Model 6937A
Lead. The system is intended to provide pacing, cardioversion and defibrillation
for treatment of patients with symptomatic drug refractory atrial fibrillation
and/or life-threatening ventricular tachyarrhythmias.
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P980053/S003
4/2/01
180-Day
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Durasphere® Injectable Bulking Agent
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Carbon Medical Technologies, Inc.
St. Paul, MN
55110
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Approval to revise the labeling’s Directions for Use to add instructions
for injection of Durasphere® via a periurethral route.
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P990009/S006
4/30/01
Real-Time
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FloSeal® Matrix and Proceed™ Hemostatic Sealants
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Fusion Medical Technologies, Inc.
Freemont, CA
94555
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Approval for the addition of language to the Package Insert regarding
the use of FloSeal® Matrix and Proceed™ Hemostatic Sealants as
agents for nasal/sinus bleeding.
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P990009/S007
4/10/01
Real-Time
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FloSeal Matrix (AKA Proceed) Hemostatic Sealant
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Fusion Medical Technologies, Inc.
Fremont, CA
94555
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Approval for the removal of the neurosurgical exclusion from the "Indications
for Use" for FloSeal Matrix® Hemostatic Sealant.
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P990028/S001
4/20/01
180-Day
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FocalSeal-L Synthetic Absorbable Sealant
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Focal, Inc.
Lexington, MA
02421
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Approval for the Post Approval Study Protocol PMS-0001-0.
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P990052/S003
4/2/01
180-Day
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Vibrant® D Soundbridge™ System (Audio Processor Models 304 and
404)
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Symphonix Devices, Inc.
San Jose, CA
95131
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Approval to change the hinge boss and to change the negative battery
contact.
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P990066/S003
4/24/01
180-Day
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Senographe 2000D Full Field Digital Mammography System
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General Electric Medical Systems
Milwaukee, WI
53201
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Approval for revised acquisition workstation (AWS) monitor specifications.
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P990074/S005
4/9/01
180-Day
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McGhan Saline-Filled Breast Implants, Style 363LF
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McGhan Medical Corporation
Santa Barbara, CA
93111
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Approval for a new series of sizes for the Style 363 saline-filled breast
implant. The device, as modified, will be marketed under the trade name
McGhan Saline-Filled Breast Implants, Style 363LF and is indicated for:
1) breast augmentation for women 18 years or older and 2) breast reconstruction.
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P000014/S004
4/19/01
180-Day
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Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators
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Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
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Approval for shipping containers, when used as stated, to maintain a
temperature within the range of 2 to 20°
C.
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P000018/S003
4/24/01
180-Day
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Novoste™
Beta-Cath™ System
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Novoste Corporation
Norcross, GA
30093
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Approval for the post-approval sutdy protocol for the Beta-Cath™
System. The post-approval study is intended to verify that the corrective
actions, intended to help minimize the incidence of device failures and
malfunctions seen during the premarket clinical investigation, are successful
in reducing the device failure and malfunction rate.
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