Premarket Approval Decisions for May 2001

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PMA Original Approvals

PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
N16420/S005 5/30/01 180-Day	Mentor Polytef Paste for Injection	Mentor Corporation Santa Barbara, CA 93111	Approval for a manufacturing site located at Mentor Corporatioin, Minneapolis, Minnesota, and for two sterilization sites located at Steris Isomedix, Inc., Minneaplois, Minnesota and BioTest Laboratories, Inc., Minneapolis, Minnesota.
N18033/S034 5/18/01 180-Day	ACUVUE® (etafilcon A) Daily Extended Wear Contact Lenses	VISTAKON Jacksonville, FL 32256	Approval for adding the manufacturing facility at VISTAKON, Johnson & Johnson (Ireland) Ltd., Limerick, Ireland, for the manufacture of ACCUVUE® (etafilcon A) Extended Wear Contact Lenses.
N50510/S141 5/14/01 180-Day	Vitek® 2 Gram Positive AST for Sparfloxacin	bioMérieus, Inc. Hazelwood, MO 63042	Approval for the addition of the antibiotic sparfloxacin at concentrations of 0.5, 1.0, and 8.0 mcg/ml to the Vitek® 2 Gram Positive Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 Gram Positive AST for Sparfloxacin and is indicated for use in Vitek® 2 Gram Positive Susceptibility Test Cards for the susceptibility testing of Staphylococcus aureus isolates to sparfloxacin in the range of <= 0.25 to >= 8 mcg/ml.
N50510/S142 5/30/01 180-Day	VITEK® Gram Positive Susceptibility (GPS) Card for Moxifloxacin	bioMérieus, Inc. Hazelwood, MO 63042	Approval for the addition to the VITEK® Gram Positive Susceptibility Panels, the antibiotic moxifloxacin at equivalent concentrations of 1, 2, and 4 mcg/ml. The device will be marketed under the trade name Vitek® Gram Positive Susceptibility (GPS) Card for Moxifloxacin, and is indicated for use in Vitek® Gram Positive Susceptibility Test Cards for the susceptibility testing of Staphylococcus aureus isolates to moxifloxacin in the range of <=0.25 to >=8 mcg/ml.
P790027/S065 5/8/01 180-Day	PMMA Anterior and Posterior Chamber Intraocular Lenses	Bausch & Lomb Surgical Claremont, CA 91711	Approval for the manufacture of the HMWX-PMMA and CC MII blank materials in the production of PMMA intraocular lenses at the Bausch & Lomb Surgical, Clearwater, Florida facility.
P790027/S066 5/8/01 180-Day	PMMA Anterior and Posterior Chamber Intraocular Lenses	Bausch & Lomb Surgical Claremont, CA 91711	Approval for the manufacture of the HMWX-PMMA and CC MII blank materials in the production of PMMA intraocular lenses at the Bausch & Lomb Surgical, Clearwater, Florida facility.
P810002/S056 5/3/01 Real-Time	St. Jude Medical® Mechanical Heart Valve – Mater Series Coated Aortic Valved Graft, Model CAVGJ-514 00	St. Jude Medical, Inc. St. Paul, MN 55117	Approval for the changes to the country of origin of the bovine collagen used for the Hemashield® graft, which is a component of the device. The device, as modified, will be marketed under the trade name St. Jude Medical® Mechanical Heart Valve – Master Series Coated Aortic Valved Graft, Model CAVGJ-514 00 in sizes 19, 21, 23, 25, 27, 29, 31, 33 mm, and is indicated for the replacement of the aortic valve and the ascending aorta.
P850059/S022 5/8/01 180-Day	PMMA Anterior and Posterior Chamber Intraocular Lenses	Bausch & Lomb Surgical Claremont, CA 91711	Approval for the manufacture of the HMWX-PMMA and CC MII blank materials in the production of PMMA intraocular lenses at the Bausch & Lomb Surgical, Clearwater, Florida facility.
P850059/S023 5/8/01 180-Day	PMMA Anterior and Posterior Chamber Intraocular Lenses	Bausch & Lomb Surgical Claremont, CA 91711	Approval for the manufacture of the HMWX-PMMA and CC MII blank materials in the production of PMMA intraocular lenses at the Bausch & Lomb Surgical, Clearwater, Florida facility.
P860003/S039 5/22/01 Real-Time	UVAR® XTS™ Photopheresis System	Therakos Exton, PA 19341	Approval for software modifications related to the enumeration of buffy coat mode cycles and to the collection volume of buffy coat prior to the irradiation process.
P860019/S173 5/16/01 Real-Time	NC MONORAIL™ PTCA Catheter	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for NC MONORAIL: PTCA catheter with WRAP-IT accessory tool. The device, as modified, is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P860019/S174 5/25/01 Real-Time	PTCA Catheters	Boston Scientific/SCIMED Maple Grove, MN 55311	Approval for a reduction of the internal diameter of the proximal shaft from 0.0205” to 0.0190” on the following catheters: Maxxum™, NC Maxxum™ and Adante™.
P860057/S015 5/15/01 180-Day	Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis Model 6900 Mitral	Edwards Lifesciences LLC Irvine, CA 92614	Approval for the post-approval study protocols and for a labeling revision based on the results of the magnetic resonance imaging study.
P860057/S017 5/15/01 180-Day	Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis Model 6900	Edwards Lifesciences LLC Irvine, CA 92614	Approval for modifications to the size 33 mm valve.
P870013/S014 5/8/01 180-Day	PMMA Anterior and Posterior Chamber Intraocular Lenses	Bausch & Lomb Surgical Claremont, CA 91711	Approval for the manufacture of the HMWX-PMMA and CC MII blank materials in the production of PMMA intraocular lenses at the Bausch & Lomb Surgical, Clearwater, Florida facility.
P870013/S015 5/8/01 180-Day	PMMA Anterior and Posterior Chamber Intraocular Lenses	Bausch & Lomb Surgical Claremont, CA 91711	Approval for the manufacture of the HMWX-PMMA and CC MII blank materials in the production of PMMA intraocular lenses at the Bausch & Lomb Surgical, Clearwater, Florida facility.
P890003/S062 5/7/01 Real-Time	Reveal Plus Insertable Loop Recorder System	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic Model 9809 Series 2.0 Software for use with the Medtronic Model 9790 Programmer series for use in programming the Model 9526 Reveal Implantable Recorder and Model 6191 Patient Activator.
P890003/S063 5/7/01 Real-Time	Model 9767/9767L Programming Head and Model 9990 Desktop Software	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic Model 9767/9767L Programming Head and Model 9990 Desktop Software.
P900061/S042 5/25/01 180-Day	Medtronic® GEM Model 7227Cx, GEM III DR Model 7275, GEM III VR Model 7231 and GEM III AT Model 7276	Medtronic, Inc. Minneapolis, MN 55432	Approval for an alternate facility for the manufacturing, packaging, and sterilization of the Model 7227Cx, Model 7275, Model 7231, and Model 7276 Implantable Cardioverter Defibrillators located at Medtronic S.A., Tolochenaz, Switzerland.
P900061/S044 5/14/01 Real-Time	Medtronic Implantable Cardioverter Defibrillators	Medtronic, inc. Shoreview, MN 55126	Approval for the general use indication for implantable cardioverter defibrillator Models Micro Jewel 7221, Micro Jewel II 7223, GEM DR 7271, GEM II DR 7273 and GEM II VR 7229 and are indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.
P910058/S010 5/9/01 180-Day	Bausch & Lomb UV-Absorbing Silicone Posterior Chamber Intraocular Lenses with Plate Haptics – Model C10UB, C11UB	Bausch & Lomb Surgical Clearwater, FL 33759	Approval for the manufacturing facility located at Bausch & Lomb Surgical, Clearwater, Florida.
P910066/S016 5/18/01 Real-Time	OL 1000, OL 1000 SC, SpinaLogic™ Bone Growth Stimulators	OrthoLogic Corporation Tempe, AZ 85281	Approval to: 1) Reformat the Patient Manuals for the OL 1000 and OL 1000 SC Bone Growth Stimulators per the recent CDRH Guidance on Medical Device Labeling, 2) Reformat the Patient Manual for the SpinaLogic™ Bone Growth Stimulator per the recent CDRH Guidance on Medical Device Labeling.
P920014/S015 5/31/01 Real-Time	HeartMate® XVE LVAS	Thoratec Corporation Woburn, MA 01888	Approval to include the HeartMate® XVE LVAS under P920014, with the same Indications for Use as for the previously approved (in Supplement S7, approval letter dated October 6, 1998) VE LVAS. The device, as modified, will be marketed under the trade name HeartMate® XVE LVAS and is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. The HeartMate® SVE LVAS is indicated for use both inside and outside the hospital.
P920023/S013 5/1/01 180-Day	UroLume® Endoprosthesis	American Medical Systems, Inc. Minnetonka, MN 55343	Approval for an automated manufacturing process to cut stents to length.
P950005/S012 5/25/01 180-Day	CELSIUS® and CELSIUS II® Diagnostic/ Ablation Deflectable Tip Catheters	Biosense Webster, Inc. Diamond Bar, CA 91765	Approval for the alternate manufacturing facility located at Biosense Webster, Inc., Juarez, Chihuahua, Mexico.
P950020/S002 5/8/01 180-Day	Cutting Balloon	Interventional Technologies, Inc. San Diego, CA 92123	Approval for the alternate manufacturing facility located at the French Valley Facility, Murrieta, California.
P950032/S023 5/9/01 Real-Time	Apligraf (Graftskin)	Organogenesis, Inc. Canton, MA 02021	Approval to introduce a new keratinocyte cell strain into the production of Apligraf (i.e., HEP 663).
P950037/S017 5/24/01 180-Day	Actros+ and Kairos Pulse Generator Families	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the use of the LITRONIK battery Model LiS 3150 in the Actros+ and Kairos Pulse Generator Families.
P960025/S006 5/14/01 180-Day	Lumbar I/F Cage® System	DePuy AcroMed Raynham, MA 02767	Approval for the following four changes to the investigational plan (IP) for the postapproval study: 1) the use of additional pedicle screw spinal systems with the I/F cage component, i.e., to allow for the use of the Ti alloy version of the VSP Spine System, the Ti alloy and stainless steel versions of the ISOLA Spine System, the TiMX Spine System and the Ti alloy and stainless steel versions of the MOSS Miami Spine System in addition to the stainless steel version of the VSP Spine System; 2) a change in the name of the device system to be evaluated in the postapproval study to be consistent with the recently approved device system name change; 3) a modification of the intra-op case report form to allow investigators to record which pedicle screw spinal system identified in item 1 above was actually implanted; and 4) a change to the required radiographic assessment methods, i.e., the optional use of T1-weighted MRI and discography.
D970003/S012 5/3/01 180-Day	PULSAR MAX II Pacemaker System and CONSULT Model 2891 Software Application	Guidant Corporation St. Paul, MN 55112	Approval for modifications to hardware and software, including the addition of the following features: Auto Sense, Ventricular Rate Regulation, Sudden Brady Response with MV Offset, and Dual Sensor Blending-Time Dependent Blend. The device, as modified, will be marketed under the trade name PULSAR MAX II Pacemaker System and CONSULT Model 2891 Software Application and is indicated for patients with any of the following conditions: 1) Symptomatic paroxysmal or permanent second- or third-degree AV block 2) Symptomatic bilateral bundle branch block 3) Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (e.g. Sinus bradycardia, sinus arrest, sinoatrial [SA] block) 4) Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhymias 5) Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes. Adaptive-rate pacing is indicated for patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity. The PULSAR MAX II series pacemakers’ dual chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of the following: A) Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block. B) VVI intolerance (e.g. pacemaker Syndrome) in the presence of persistent sinus rhythm.
P970003/S031 5/1/01 Real-Time	NeuroCybernetic Prosthesis (NCP) System Model 300 NCP Bipolar Lead (Single Ribbon Electrode)	Cyberonics, Inc. Houston, TX 77058	Approval for the NeuroCybernetic Prosthesis (NCP) System Model 300 NCP Bipolar Lead (Single Ribbon Electrode).
P970003/S032 5/10/01 180-Day	NeuroCybernetic Prosthesis (NCP) System	Cyberonics, Inc. Houston, TX 77058	Approval for a new sterilization site located at Steritec, Inc., Athens, Texas, as well as labeling process and packaging changes, and a combined model physician’s manual.
P970018/S002 5/25/01 180-Day	AutoCyte PREP System	TriPath Imaging Redmond, WA 98052	Approval for the addition of the PREPMATE accessory (PREPMATE method), which automates the initial manual steps of the AutoCyte PREP laboratory process.
P970020/S027 5/7/01 Real-Time	ACS Multi-Link RX and OTW Penta™ Coronary Stent Systems	Guidant Corporation Santa Clara, CA 95052	Approval for the ACS Multi-Link RX and OTW Penta™ Coronary Stent Systems. The devices are indicated for improving coronary lumen diameter in the following: 1) Patients with synmptomatic ischemic disease due to discrete de novo or restenotic native coronary artery lesions (length <=25 mm) with a reference vessel diameter of 3.0 mm to 4.0 mm; and 2) Treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (<= mm in length) with reference diameters in the range of 2.5 mm to 4.0 mm. Long term outcome for this permanent implant is unknown at present. Note: The 2.5 mm and 2.75 mm diameters, and 33 mm and 38 mm length stents are solely indicated for use in patients with abrupt or threatened abrupt closure.
P970058/S010 5/29/01 180-Day	ImageChecker M1000	R2 Technology, Inc. Los Altos, CA 94022	Approval for the expansion of the Indications for Use to cover diagnostic as well as screening mammograms. The new indications for use is: The ImageChecker M1000 is a computer system intended to identify and mark regions of interest on routine screening and diagnostic mammograms to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.
P980001/S032 5/29/01 Real-Time	NIR Premounted Stent Systems	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for a reduction of the internal diameter of the proximal shaft from 0.0205” to 0.0190” on the following premounted stent systems: NIROYAL(™) Advance, NIROYAL™ Elite and NIR™ Elite.
P980016/S016 5/25/01 180-Day	Medtronic® GEM Model 7227Cx, GEM III DR Model 7275, GEM III VR Model 7231 and GEM III AT Model 7276	Medtronic, Inc. Minneapolis, MN 55432	Approval for an alternate facility for the manufacturing, packaging, and sterilization of the Model 7227Cx, Model 7275, Model 7231, and Model 7276 Implantable Cardioverter Defibrillators located at Medtronic S.A., Tolochenaz, Switzerland.
P980016/S018 5/14/01 Real-Time	Medtronic Implantable Cardioverter Defibrillators	Medtronic, inc. Shoreview, MN 55126	Approval for the general use indication for implantable cardioverter defibrillator Models Micro Jewel 7221, Micro Jewel II 7223, GEM DR 7271, GEM II DR 7273 and GEM II VR 7229 and are indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.
P980035/S010 5/14/01 Special	Medtronic Kappa 700/600 Pulse Generator Family	Medtronic, Inc. Shoreview, MN 55126	Approval for modifications to the epoxy application pattern and a wire bond loop program in the referenced family of pulse generators.
P980048/S001 5/2/01 180-Day	BAK/Cervical (BAK/C) Interbody Fusion System	Sulzer Spine-Tech Minneapolis, MN 55439	Approval for a sterilization facility located at Steris Isomedix Services, Minneapolis, Minnesota.
P980050/S003 5/25/01 180-Day	Medtronic® GEM Model 7227Cx, GEM III DR Model 7275, GEM III VR Model 7231 and GEM III AT Model 7276	Medtronic, Inc. Minneapolis, MN 55432	Approval for an alternate facility for the manufacturing, packaging, and sterilization of the Model 7227Cx, Model 7275, Model 7231, and Model 7276 Implantable Cardioverter Defibrillators located at Medtronic S.A., Tolochenaz, Switzerland.
P980050/S004 5/22/01 Real-Time	Medtronic Model 7276 GEM III AT Implantable Defibrillator	Medtronic, Inc. Shoreview, MN 55126	Approval for labeling for the Model 7276 GEM III AT Implantable Defibrillator which reflects the “AF only” indication (i.e., indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias).
P990020/S007 5/9/01 180-Day	The AneuRx™ Stent Graft System	Medtronic AVE Santa Rosa, CA 95407	Approval for modifications to the delivery catheter for the 28 mm AneuRx Stent Graft System.
P990026/S001 5/3/01 Real-Time	GlucoWatch® Automatic Glucose Biographer	Cygnus, Inc. Redwood City, CA 94063	Approval for the addition of a preservative in the AutoSensors.
P990026/S002 5/22/01 Real-Time	GlucoWatch® Automatic Glucose Biographer	Cygnus, Inc. Redwood City, CA 94063	Approval for modifications to the AutoSensor packaging.
P990040/S001 5/30/01 180-Day	TRUFILL® n-Butyl Cyanoacrylate (n-BCA) LIQUID Embolic System	Cordis Neurovascular, Inc. Miami Lakes, FL 33014	Approval for removal of the post ethylene oxide sterilization pyrogen test of the n-BCA, removal of the post-sterilization functional testing of the Tantalum Powder, the addition of a pyrogen test of the Tantalum Powder, and the validation of the pyrogenicity test.
P990046/S001 5/10/01 180-Day	ATS Open Pivot® Bileaflet Heart Valve	ATS Medical, Inc. Minneapolis, MN 55447	Approval for valve sizes 16/19 mm aortic and 24/27 mm mitral and the addition of a valve resterilization instruction in the labeling.
P990046/S003 5/10/01 180-Day	ATS Open Pivot® Bileaflet Heart Valve	ATS Medical, Inc. Minneapolis, MN 55447	Approval for valve sizes 16/19 mm aortic and 24/27 mm mitral and the addition of a valve resterilization instruction in the labeling.
P990074/S006 5/15/01 180-Day	Saline-Filled Breast Implants	McGhan Medical Corporation Santa Barbara, CA 93111	Approval for moving the manufacturing and dry heat sterilization of Saline-Filled Breast Implants to McGhan Medical Corporation, Santa Barbara, California.
P990086/S001 5/1/01 180-Day	HealthTronics OssaTron®	HealthTronics, Inc. Marietta, GA 30062	Approval for the post market approval study protocol.
P000011/S001 5/7/01 180-Day	BiodivYsio™ AS PC (phosphorylcholine) Coated Stent and Delivery System	Biocompatibles Cardiovascular, Inc. Rockville, MD 20852	Approval for the post-approval studey protocol foror the BiodivYsio™ AS PC (phosphorylcholine) Coated Stent and delivery System.
P000020/S001 5/18/01 180-Day	Stinger™ and Stinger S™ Ablation Catheter and TempLink™ Extension Cable	C.R. Bard, Inc. Lowell, MA 01851	Approval for a change to the materials of the catheter tip to increase its stiffness and other minor device modifications. The device, as modified, will be marketed under the trade name Stinger™ S Ablation Catheter and is indicated for creating focal endocardial lesions during cardiac ablation procedures to treat arrhythmias, and for cardiac electrophysiological mapping and delivering diagnostic pacing stimuli.

Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 51

Summary of PMA Originals Under Review
Total Under Review: 83
Total Active: 37
Total On Hold: 46
Number Greater Than 180 Days: 1

Summary of PMA Supplements Under Review
Total Under Review: 260
Total Active: 157
Total On Hold: 103
Number Greater Than 180 Days: 6

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 51
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 161.0

30-Day Notices (135 Day Supplement was not required)
APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P810046/S207 5/24/01	HighSail™ Coronary Dilatation Catheter	Guidant Corporation Temecula, CA 92591	Manufacturing change to modify the sidearm assembly and inspection process.
P860019/S171 5/1/01	Boston Scientific Scimed PTCA Catheters	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Change to eliminate the use of creep testing and use only burst testing as a single standard for determining packaging seal strength integrity at incoming inspection and online production.
P860019/S172 5/2/01	NC Maxxum PTCA Catheter	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Alternate manufacturing process for tri-forming balloons in the manufacture of the NC Maxxum PTCA Catheter System using the Soft V-Blade Balloon Former Machine.
P900056/S063 5/21/01	Rotablator Rotational Angioplasty System	Boston Scientific Corporation. Redmond, WA 98052	Transfer of the burr plating process to the Boston Scientific Cork Ltd. Facility.
P930031/S009 5/29/01	WALLSTENT® Transjugular Intrahepatic Portosystemic Shunt (TIPS) Endoprosthesis	Boston Scientific /Scimed Maple Grove, MN 55311	Change to the internal action level for particulate count of finished product.
P940019/S007 5/29/01	WALLSTENT® Iliac Endoprosthesis	Boston Scientific /Scimed Maple Grove, MN 55311	Change to the internal action level for particulate count of finished product.
P950018/S006 5/15/01	Perfluoron	Alcon Research, Inc. Fort Worth, TX 76134	Elimination of redundant in process testing for %PfnO, Fluoride Ion, Non-Volatile Residues and Heavy Metals.
P970020/S032 5/24/01	ACS MULTI-LINK RX and OTW ULTRA™ Coronary Stent Systems	Guidant Corporation Santa Clara, CA 95054	Change to the manufacturing process for stent production.
P970035/S026 5/3/01	S670 With Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems, S660 With Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems	Medtronic AVE, Inc. Santa Rosa, CA 95403	Option to use a laser to bond the marker band to the inner-member of the catheters.
P970035/S027 5/29/01	S7 with Discrete Technology™ Over-the Wire Coronary Stent System and S7 with Discrete Technology™ Rapid Exchange Coronary Stent System	Medtronic AVE, Inc. Santa Rosa, CA 95403	Change to the manufacturing process to increase the length and inner diameter of the third and fourth TFE baking sheaths in size to facilitate their application during the stent/balloon baking process.
P000022/S005 5/3/01	BeStent™ 2 With Discrete Technology™ Rapid Exchange Coronary Stent Systems	Medtronic AVE, Inc. Santa Rosa, CA 95403	Option to use a laser to bond the marker band to the inner-member of the catheters.
P000044/S001 5/24/01	Vitros Immunodiagnostic Products HBsAg Reagent Pack, Calibrator, and Confirmatory Kit	Ortho-Clinical Diagnostic, Inc. Rochester, NY 14626	Change to the type of dispenser used to dispense the coating solution and wash buffers during the manufacture of the coated microwells, a component of the product.

PMA Final Decisions Rendered for May 2001

PMA Original Approvals