The Food & Drug Administration released a list of pre-market approvals granted in February:
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P080003
2/11/11 |
Selenia Dimensions 3D System | Hologic, Inc.
Bedford, MA 01730 |
Approval for the Selenia Dimensions 3D System. This device is indicated to generate digital mammographic images that can be used for screening and diagnosis of breast cancer. The Selenia Dimensions (2D or 3D) system is intended for use in the same clinical applications as 2D mammography systems for screening mammograms. Specifically, the Selenia Dimensions system can be used to acquire 2D digital mammograms and 3D mammograms. The screening examination will consist of a 2D image set or a 2D and 3D image set. The Selenia Dimensions system may also be used for additional diagnostic workup of the breast. |
| P090013
2/8/11 |
Revo MRI™ SureScan™ Pacing System | Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the Revo MRI
SureScan Pacing System, which consists of the Medtronic Revo MRI™ SureScan™ Model RVDR01 IPG, the Medtronic CapSureFix MRI™ SureScan™ 5086MRI lead, and the Revo MRI™ Software Application Model SW018. This system is indicated as follows: The Medtronic Revo MRI™ SureScan™ Model RVDR01 IPG is indicated for use as a system consisting of a Revo MRI SureScan IPG implanted with two CapSure Fix MRI™ SureScan™ 5086MRI leads. A complete system is required for use in the MRI environment. The Medtronic Revo MRI™ SureScan™ Model RVDR01 IPG is indicated for the following: 1) Rate adaptive pacing in patients who may benefit from increased pacing rales concurrent with increases in activity; 2) Accepted patient conditions warranting chronic cardiac pacing include: a) symptomatic paroxysmal or permanent second-degree or third-degree AV block; b) symptomatic bilateral bundle branch block; c) symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders; and d) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias. The device is 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 and AV synchrony, which include: 1) Various degrees of AV block to maintain the atrial contribution to cardiac output; and 2) VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmia in bradycardia patients with one or more of the above pacing indications. Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmia in bradycardia patients with atrial septal lead placement and one or more of the above pacing indications. The Medtronic CapSureFix MRI™ SureScan™ 5086MRI lead is indicated for use as a system consisting of a Medtronic Revo MRI™ SureScan™ Model RVDR01 IPG implanted with two SureScan leads. A complete system is required for use in the MRI environment. This lead has application where implantable dual chamber MR Conditional pacing systems are indicated. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P810025/S028
2/25/11 180-Day |
Amvisc® and Amvisc® Plus Ophthalmic Viscosurgical Devices (OVD) | Bausch & Lomb, Inc.
Aliso Viejo, CA 92656 |
Approval for an alternate raw material source and alternate manufacturing site (Lifecore Biomedical, LLC, Chaska, MN) for raw material and finished products. |
| P830055/S107
2/22/11 180-Day |
LCS Total Knee System | DePuy Orthopaedics, Inc. Warsaw, IN
46581 |
Approval to manufacture the P.F.C. Sigma RP-F, LCS Complete RP, and RPS Tibial Inserts from GUR 1020 polyethylene with an antioxidant (AOX), to change the packaging components and materials, and to request approval of a shelf-life testing protocol for the P.F.C. Sigma RP-F, LCS Complete RP and RPS Tibial Inserts. |
| P850048/S024
2/7/11 Special |
Access® Hybritech® PSA Reagents on the Access® Immunoassay Systems | Beckman Coulter, Inc.
Chaska, MN 55318 |
Approval to add the following new warning label to all Access DxI systems. “Warning” Erroneous results can occur if reagent packs are not loaded properly. 1) Never transfer a partial reagent pack that was used on a different system.
2) Always load a reagent pack before scanning the bar code (Access/ Access 2 only). For specific instructions, consult the system documentation. |
| P850048/S025
2/4/11 Special |
Access® Hybritech® PSA Reagents on the Access® Immunoassay Systems | Beckman Coulter, Inc.
Chaska, MN 55318 |
Approval for the following changes: 1) modify the fluidics interconnect panels to add tube clips; 2) additional tubing labels which correspond with fluidic interconnect panel; 3) add strain relief as a bend deterrent; and 4) update maintenance documentation to reflect modified configuration. |
| P910073/S092
2/11/11 Real-Time |
RELIANCE 4-Site Defibrillation Lead | Boston Scientific
St. Paul, MN 55112 |
Approval for a decrease in the length of the polyurethane tubing present at the proximal end of the lead and a labeling note regarding implantation technique. |
| P950005/S031
2/3/11 180-Day |
Celsius RMT Catheter (4mm) | Biosense Webster Diamond Bar, CA 91765 | Approval for a manufacturing site located at Biosense Webster, Inc, Juarez, Mexico. |
| P950032/S059
2/14/11 135-Day |
Apligraf® | Organogensis Incorporated
Canton, MA 02021 |
Approval to use a rapid microbial method, as an alternate sterility testing method for all in-process liquid samples currently tested per United States Pharmacopeia <71>, Sterility Tests. |
| P950037/S092
2/11/11 Real-Time |
Estella DR ;
Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR |
Biotronik, Inc.
Lake Oswego, OR 97035 |
Approval for the ICS 3000 Programmer Application Software Version PSW 1004.U. The modified devices will be marketed under the following tradenames: the Estella DR; Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR. |
| P960013/S063
2/3/11 135-Day |
Tendril Leads | St. Jude Medical, Inc.
Sylmar, CA 91392 |
Approval for the use of an alternate supplier for the manufacture of shaft assemblies. |
| P960022/S007
2/18/11 180-Day |
Bausch & Lomb® SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lenses | Bausch & Lomb, Inc.
Rochester, NY 14609 |
Approval for a name change to the currently marketed Bausch & Lomb® SofLens® 66 Toric (alphafilcon A) Visibility tinted Contact Lenses. The proposed name for the device is Bausch & Lomb® SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lenses. |
| P970038/S013
2/7/11 Special |
Access® Hybritech® Free PSA Reagents on the Access® Immunoassay Systems | Beckman Coulter, Inc.
Chaska, MN 55318 |
Approval to add the following new warning label to all Access DxI systems. “Warning” Erroneous results can occur if reagent packs are not loaded properly. 1) Never transfer a partial reagent pack that was used on a different system. 2) Always load a reagent pack before scanning the bar code (Access/
Access 2 only). For specific instructions, consult the system documentation. |
| P970038/S014
2/4/11 Special |
Access® Hybritech® Free PSA Reagents on the Access® Immunoassay Systems | Beckman Coulter, Inc.
Chaska, MN 55318 |
Approval for the following changes: 1) modify the fluidics interconnect panels to add tube clips; 2) additional tubing labels which correspond with fluidic interconnect panel; 3) add strain relief as a bend deterrent; and 4) update maintenance documentation to reflect modified configuration. |
| P980018/S011
2/17/11 180-Day |
Herceptest™ Kit | Dako Denmark A/S Glostrup, Denmark
DK-2600 |
Approval of the DakoLink v3.1.0. software for Herceptest™ kit. |
| P980022/S087
2/17/11 135-Day |
Paradigm Real Time System | Medtronic, Inc. Northridge, CA 91325 | Approval of the addition of an alternate vendor for the Dynaroll battery tube. |
| P980023/S043
2/28/11 Real-Time |
Linox smart S and Linox smart T Steroid- Eluting Single Coil ICD Leads | Biotronik, Inc.
Lake Oswego, OR 97035 |
Approval for: 1) addition of Silglide surface treatment of the silicone lead body; 2) increase in outer diameter of lead body at DF-1 connector exit; and 3) additional suppliers for silicone and conductor materials. |
| P980041/S014
2/7/11 Special |
Access® AFP Reagents on the Access® Immunoassay Systems | Beckman Coulter, Inc.
Chaska, MN 55318 |
Approval to add the following new warning label to all Access DxI systems. “Warning” Erroneous results can occur if reagent packs are not loaded properly. 1) Never transfer a partial reagent pack that was used on a different system. 2) Always load a reagent pack before scanning the bar code (Access/
Access 2 only). For specific instructions, consult the system documentation. |
| P980041/S015
2/4/11 Special |
Access® AFP Reagents on the Access® Immunoassay Systems | Beckman Coulter, Inc.
Chaska, MN 55318 |
Approval for the following changes: 1) modify the fluidics interconnect panels to add tube clips; 2) additional tubing labels which correspond with fluidic interconnect panel; 3) add strain relief as a bend deterrent; and 4) update maintenance documentation to reflect modified configuration. |
| P980049/S062
2/10/11 Real-Time |
Paradym ICD and CRT-D | ELA Medical, Inc./ Sorin Group
Plymouth, MN 5541 |
Approval for the changes to the transformer, Opto Wedge, and Desiccant for the Paradym ICD and CRT-D Models 8250, 8550, and 8750. |
| P990025/S026
2/3/11 180-Day |
NaviStar RMT Catheter (4mm) | Biosense Webster Diamond Bar, CA 91765 | Approval for a manufacturing site located at Biosense Webster, Inc, Juarez, Mexico. |
| P000008/S017
2/16/11 Panel-Track |
LAP-BAND™ Adjustable Gastric Banding System | Allergan, Inc. Goleta, CA
93117 |
Approval for LAP-BAND™ Adjustable Gastric Banding System. The LAP-BAND™ System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m 2
or a BMI of at least 30 kg/ m 2 with one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives. |
| P000009/S043
2/11/11 Real-Time |
Estella DR ;
Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR |
Biotronik, Inc.
Lake Oswego, OR 97035 |
Approval for the ICS 3000 Programmer Application Software Version PSW 1004.U. The devices, as modified will be marketed under the following tradenames: the Estella DR; Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR. |
| P000018/S044
2/23/11 180-day |
Beta-Cath™ System | Best Vascular, Inc. Norcross, GA
30093 |
Approval of the post-approval study protocol. |
| P010013/S032
2/18/11 135-Day |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc.
Marlborough, MA 01752 |
Approval for a change to the molded manifold component to require the component to be annealed. |
| P010030/S024
2/18/11 Real-Time |
LifeVest Wearable Defibrillators | Zoll Lifecor Corporation
Pittsburgh, PA 15238 |
Approval for software changes including asystole notification handling, low battery notification handling, and power up response button sequence in addition to labeling updates resulting from those changes. |
| P010032/S036
2/11/11 Real-Time |
Eon Neurostimulation (IPG) System | St. Jude Medical
Plano, Texas 75024 |
Approval for adding heat shrink tubing to the conductors of the coaxial cable of the Charging Antenna which is used with the Eon IPG System. |
| P010032/S037
2/24/11 Real-Time |
Eon Neurostimulation (IPG) System | St. Jude Medical
Plano, Texas 75024 |
Approval for antenna spacer disks for the Model 3701 Eon wall charger kit. |
| P010047/S001
2/17/11 180-Day |
NeoMend ProGEL Pleural Air Leak Sealant | Neomend, Inc.
Irvine, CA 92618 |
Approval of the post-approval study protocol. |
| P010068/S021
2/3/11 180-Day |
NaviStar RMT DS Catheter (8mm) | Biosense Webster Diamond Bar, CA 91765 | Approval for a manufacturing site located at Biosense Webster, Inc, Juarez, Mexico. |
| P020014/S032
2/24/11 Real-Time |
Conceptus Essure® System for Permanent Birth Control | Conceptus, Inc. Mountain View, CA
94041 |
Approval for design changes to the duckbill valve of the valved introducer and changes to the length of the delivery wire. |
| P020026/S026
2/22/11 180-Day |
4.00mm CYPHER® Sirolimus-Eluting Coronary Stent on RAPTORRAIL® Rapid Exchange (RX) Delivery System | Cordis Corporation Miami, FL
33102 |
Approval for the 4.0mm CYPHER® Sirolimus-eluting Coronary Stent on RAPTORRAIL® (RX) Delivery System. The device, as modified will be marketed under the trade name 4.00mm CYPHER® Sirolimus-eluting Coronary Stent on RAPTORRAIL® Rapid Exchange Delivery System and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length ≤ 30 mm in native coronary arteries with a reference vessel diameter of ≥ 2.25 to ≤ 4.0 mm. |
| P020036/S016
2/14/11 Real-Time |
SMART Nitinol Stent System and SMART Control Nitinol Stent System | Cordis Corporation Bridgewater, NJ
08807 |
Approval for a change in colorant used in the catheters of the PRECISE and SMART Nitinol Stent Systems. |
| P020047/S023
2/3/11 135-Day
|
MULTI-LINK – 8™, MULTI-LINK – 8™ LL, and MULTI-LINK – 8™ SV Coronary Stent Systems | Abbott Vascular
Temecula, CA 92590 |
Approval for: 1) the addition of sensors for monitoring the coating process; and 2) minor tooling upgrades. |
| P030024/S014
2/28/11 135-Day |
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator | Ortho Clinical Diagnostics, Inc. Cardiff, United Kingdom | Approval for a change in the manufacturing scale for a component reagent. |
| P030047/S019
2/14/11 Real-Time |
PRECISE, PRECISE Rx, and PRECISE PRO Rx Nitinol Stent Systems | Cordis Corporation Bridgewater, NJ
08807 |
Approval for a change in colorant used in the catheters of the PRECISE and SMART Nitinol Stent Systems. |
| P030054/S155
2/11/11 Real-Time |
DSA0006 Slit Suture Sleeve Accessory | St. Jude Medical
Sylmar, CA 91342 |
Approval for a new 4.3-4.7 Fr slit suture sleeve accessory kit to be used with the approved 1258T Quickflex μ lead. |
| P040006/S005
2/8/11 Special |
In Motion® Lumbar Artificial Disc | DePuy Spine, Inc. Raynham, MA 02767 | Approval for the change in tolerance of the implant dimensions and the subsequent independent inspection of these dimensions. |
| P040043/S037
2/24/11 180-Day |
GORE TAG Thoracic Endoprosthesis | W.L. Gore and Associates, Inc. Flagstaff, AZ
86001 |
Approval to update the GORE TAG Thoracic Endoprosthesis instructions for use to include summary information on the evaluation of the physician training program for this device. |
| P040050/S007
2/4/11 180-Day |
Macroplastique Implants | Uroplasty, Inc.
Minnetonka, MN 55343 |
Approval for a contract gamma sterilization site located at Steris/Isomedix Contract Sterilization Services, Libertyville, Illinois. |
| P050010/S008
2/16/11 Real-Time |
ProDisc-L Total Disc Replacement | Synthes Spine
West Chester, PA 19380 |
Approval for MR Conditional Labeling. |
| P050023/S041
2/11/11 Real-Time |
Estella DR ;
Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR |
Biotronik, Inc.
Lake Oswego, OR 97035 |
Approval for the ICS 3000 Programmer Application Software Version PSW 1004.U. The devices, as modified will be marketed under the following tradenames: the Estella DR; Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR. |
| P050034/S004
2/4/11 Real-Time |
Implantable Miniature Telescopes™ (IMT) | VisionCare Ophthalmic Technologies Saratoga, CA
95070 |
Approval for extending the shelf life of the IMT from 2 years to 3 years. |
| P050044/S016
2/4/11 Special |
Vitagel Surgical Hemostat | Orthovita, Inc. Malvern, PA
19355 |
Approval for an additional in- process inspection of the Transfer Syringes to visually check that the caps are present and appropriately tightened. |
| P060019/S009
2/23/11 180-Day |
Safire BLU and Therapy Cool Path Bi-Directional Ablation Catheters | St. Jude Medical Irvine, CA
92614 |
Approval to add bi-directional steering to the Therapy Cool Path Ablation Catheter. The devices, as modified, will be marketed under the trade names Safire BLU Irrigated Ablation Catheter and Therapy Cool Path Ablation Catheter. |
| P060027/S029
2/10/11 Real-Time |
Paradym ICD and CRT-D | ELA Medical, Inc./ Sorin Group
Plymouth, MN 55441 |
Approval for changes to the transformer, Opto Wedge, and Desiccant for the Paradym ICD and CRT-D Models 8250, 8550, and 8750. |
| P070001/S009
2/16/11 Real-Time |
ProDisc-C Total Disc Replacement | Synthes Spine
West Chester, PA 19380 |
Approval for MR Conditional Labeling. |
| P070008/S021
2/11/11 Real-Time |
Estella DR ;
Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR |
Biotronik, Inc.
Lake Oswego, OR 97035 |
Approval for the ICS 3000 Programmer Application Software Version PSW 1004.U. The devices, as modified will be marketed under the following tradenames: the Estella DR; Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR. |
| P070015/S046
2/3/11 135-Day |
XIENCE V® and PROMUS™ Everolimus Eluting Coronary Stent Systems | Abbott Vascular, Inc.
Temecula, CA 92591 |
Approval for changes to the testing plan for the drug substance. |
| P080013/S003
2/18/11 180-Day |
DuraSeal Spine Sealant System | Covidien
Bedford, MA 01730 |
Approval for the replacement of the current DuraSeal Spine Sealant polyethylene glycol (PEG) formulation with a lower molecular weight formulation. |
| P080015/S003
2/3/11 Real-Time |
Cervista HPV 16/18 | Hologic, Inc.
Marlborough, MA 01752 |
Approval for several changes to the Cervista HPV 16/18 software and labeling. Changes include numerous user interface changes, and separating the Invader Call Reporter and Cervista HPV 16/18 software on to separate CDs with new part numbers. |
| P080027/S001
2/18/11 Panel-Track |
OraQuick® HCV Rapid Antibody Test | OraSure Technologies, Inc. Bethlehem, PA 18015 | Approval for the OraQuick® HCV Rapid Antibody Test. The device is a single-use immunoassay for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in fingerstick whole blood specimens and venipuncture whole blood specimens (EDTA, sodium heparin, lithium heparin, and sodium citrate) from individuals 15 years or older. The OraQuick® HCV Rapid Antibody Test results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HCV (state of infection or associated disease not determined) in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis C infection. |
| P080032/S004
2/4/11 180-Day |
Alair Bronchial Thermoplasty System | Boston Scientific Corporation
St. Paul, MN 55112 |
Approval for adding gamma irradiation as an alternative sterilization method, establishing expiration dating for that sterilization method, and adding Sterigenics (Hayward, California) as a contract sterilizer. |
| P090003/S005
2/3/11 135-Day |
Express® LD Iliac Pre-mounted Stent System | Boston Scientific Corporation
Maple Grove, MN 55311 |
Approval for multiple component-specific manufacturing process changes. |
| P090006/S002
2/15/11 180-Day |
Complete SE Vascular Stent System | Medtronic Vascular Santa Rosa, CA
95403 |
Approval for the 120mm length Complete SE Vascular Stent. |
| P090022/S004
2/2/11 Real-Time |
Softec HD PS Posterior Chamber Intraocular Lens (PCIOL) | Lenstec, Inc.
St. Petersburg, FL 33716 |
Approval to extend the power range for which lenses are marketed in 1/4 diopter increment from 18.0 through 25.0 diopters to 15.0 through 25.0 diopters. The device, as modified, will be marketed under the trade name Softec HD PS Posterior Chamber Intraocular Lens (PCIOL) and is indicated for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21. The lens is indicated for capsular bag placement. |
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 |
|---|---|---|---|
| N16895/S092
2/9/11 |
Bausch & Lomb SofLens (polymacon) Visibility Tinted Contact Lenses | Bausch & Lomb, Inc.
Rochester, NY 14609 |
Change in supplier location. |
| N18033/S051
2/14/11 |
VISTAKON® (etafilcon A) Soft Contact Lenses | Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256 |
Implementation of an alternate test method for determining the purity in the raw material, N,N-Dimethyacrylamide, used in the VISTAKON® (etafilcon A) Soft Contact Lenses. |
| N18033/S052
2/14/11 |
VISTAKON® (etafilcon A) Soft Contact Lenses | Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256 |
Implementation of an automated process for verifying lot data prior to printing labels for VISTAKON® (etafilcon A) Contact Lenses. |
| N18033/S053
2/14/11 |
VISTAKON® (etafilcon A) Soft Contact Lenses | Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256 |
Implementation of an alternate test method for determining the purity in the raw material, Methacrylic Acid, used in the VISTAKON® (etafilcon A) Soft Contact Lenses. |
| P810002/S072
2/7/11 |
St. Jude Medical Mechanical Heart Valve | St. Jude Medical
St. Paul, MN 55117 |
Change in gel fixation time. |
| P880086/S197
2/23/11 |
Affinity, Integrity, Victory, Zephyr, and Accent Families of Pacemakers | St. Jude Medical, Inc.
Sylmar, CA 91342 |
Change to the setscrew and septum installation process. |
| P890003/S212
2/24/11 |
Prodigy Family of IPGs | Medtronic, Inc.
Mounds View, MN 55112 |
Revision of parameters to an epoxy dispense manufacturing process. |
| P910001/S043
2/3/11
|
ELCA Coronary Atherectomy Catheters | Spectranetics Corporation
Colorado Springs, CO 80921 |
Use of additional pouch sealing equipment. |
| P910001/S044
2/28/11
|
ELCA Coronary Atherectomy Catheters | Spectranetics Corporation
Colorado Springs, CO 80921 |
Modifications to the glass preform process. |
| P930038/S065
2/18/11 |
Angio-Seal™ Vascular Closure Device | St. Jude Medical
St. Paul, MN 55117 |
Reduction in the frequency of an in- process quality control inspection. |
| P950022/S076
2/10/11 |
Durata Family of Leads | St. Jude Medical Sylmar, CA
91342 |
Use of an alternate supplier for a lead component. |
| P950032/S062
2/10/11 |
Apligraf | Organogenesis, Inc. Canton, MA
02021 |
Alternate supplier for the polycarbonate base film used in the manufacture of a culture insert. |
| P960042/S025
2/9/11 |
Spectranetics Laser Sheath II (SLS II) | Spectranetics Corporation
Colorado Springs, CO 80921 |
Change to the fusing process for the outer jacket tubing. |
| P960042/S026
2/28/11
|
Spectranetics Laser Sheath II (SLS II) | Spectranetics Corporation
Colorado Springs, CO 80921 |
Modifications to the glass preform process. |
| P970003/S120
2/17/11 |
VNS Therapy® System | Cyberonics, Inc.
Houston, TX 77058 |
Addition of alternate raw materials and removal of associated cleaning steps. |
| P970003/S121
2/28/11 |
VNS Therapy® System | Cyberonics, Inc.
Houston, TX 77058 |
Change to the pulse generator manufacturing process. |
| P970012/S082
2/24/11 |
Kappa 400 Family of IPGs | Medtronic, Inc.
Mounds View, MN 55112 |
Revision of parameters to an epoxy dispense manufacturing process. |
| P970021/S032
2/16/11
|
Gynecare Thermachoice III Uterine Balloon Therapy System | ETHICON, Inc. Somerville, NJ
08876 |
Use of a new sub- tier supplier for the printed circuit board assembly. |
| P970021/S033
2/25/11 |
Gynecare Thermachoice III Uterine Balloon Therapy System | ETHICON, Inc.
Somerville, NJ 08876 |
Change in the cleaning solution used in removing residue from the heating wire during the manufacturing process. |
| P980016/S274
2/3/11 |
Virtuoso, Secura DR/VR, Maximo II DR/VR, and Virtuoso II VR/DR ICDs | Medtronic, Inc.
Mounds View, MN 55112 |
Reduction in the frequency of a quality control test for the Laser Ribbon Bonding (LRB) process. |
| P980016/S275
2/10/11 |
Maximo II DR /VR, Virtuoso II DR/VR and Secura DR/VR | Medtronic, Inc. Mounds View, MN 55112 | Updates to test software used during final functional device testing. |
| P980016/S276
2/17/11 |
Maximo II DR /VR, Virtuoso II DR/VR, Secura DR/VR, Virtuoso, EnTrust, Marquis, Maximo and Intrinsic Families of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Implementation of a detection step in the battery manufacturing process at a supplier. |
| P980016/S277
2/24/11 |
Entrust, Intrinsic, Marquis, Maximo, Maximo II, Secura, Virtuoso and Virtuoso II Families of ICDs | Medtronic, Inc.
Mounds View, MN 55112 |
Revision of parameters to an epoxy dispense manufacturing process. |
| P980016/S279
2/23/11 |
Entrust ICD, Intrinsic, Marquis, Maximo, Maximo ICD, Maximo II DR/VR, Secura DR/VR ICD, Virtuoso ICD, Virtuoso II DR/VR ICD | Medtronic, Inc. Mounds View, MN 55112 | Automation of an additional plating line. |
| P980018/S012
2/11/11 |
HercepTest™ | Dako Denmark A/S Glostrup, Denmark | Automated filling of DAB chromogen for HercepTest™ as the primary filling process. |
| P980035/S201
2/24/11 |
Medtronic 350 Series, Adapta, AT500, EnPulse, EnRhythm, Kappa 700/800/900, Relia, Sensia, Sigma, and Versa Families of IPGs | Medtronic, Inc.
Mounds View, MN 55112 |
Revision of parameters to an epoxy dispense manufacturing process. |
| P980035/S202
2/23/11 |
Adapta, Versa, Sensia, EnRhythm, Relia IPGs | Medtronic, Inc. Mounds View, MN 55112 | Automation of an additional plating line. |
| P990001/S083
2/24/11 |
Vitatron DA+ C-Series and DA+ T-Series Families of IPGs | Medtronic, Inc.
Mounds View, MN 55112 |
Revision of parameters to an epoxy dispense manufacturing process. |
| P990001/S084
2/23/11 |
Vitatron DA+ C-Series, and
DA+ T-Series Families of IPGs |
Medtronic, Inc. Mounds View, MN 55112 | Automation of an additional plating line. |
| P990020/S044
2/7/11 |
AneuRX AAAdvantage Stent Graft System | Medtronic Vascular
Santa Rosa, CA 95403 |
Change to sample numbers for Endotoxin Testing and a lot definition change. |
| P000037/S022
2/16/11 |
On-X® Prosthetic Heart Valve | On-X Life Technologies, Inc. | Added production capability for two currently outsourced machining processes. |
| P000039/S039
2/18/11 |
AMPLATZER® Septal Occluder | AGA Medical Corporation
Plymouth, MN 55442 |
Use of new patch forming equipment. |
| P010001/S008
2/25/11 |
Ceramic TRANSCEND® Hip Articulation System | CeramTec GmbH
Plochingen, Germany |
Addition of two “like to like” machines used for the following manufacturing processes of the ceramic ball heads: 1) grinding the inner bore and chamfer; and 2) polishing the outer ball head contour. |
| P010015/S108
2/24/11 |
InSync and InSync III Families of CRT-Ps | Medtronic, Inc.
Mounds View, MN 55112 |
Revision of parameters to an epoxy dispense manufacturing process. |
| P010031/S229
2/3/11 |
Consulta, Consulta II, Maximo II and Concerto CRT-Ds | Medtronic, Inc.
Mounds View, MN 55112 |
Reduction in the frequency of a quality control test for the Laser Ribbon Bonding (LRB) process. |
| P010031/S230
2/10/11 |
Concerto II CRT-D, Maximo II CRT-D, and Consulta CRT-D | Medtronic, Inc.
Mounds View, MN 55112 |
Updates to test software used during final functional device testing. |
| P010031/S231
2/17/11 |
Concerto II, Maximo II, Consulta, Concerto, InSync Maximo, InSync Sentry, InSync II Marquis, and InSync III Marquis Families of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 | Implementation of a detection step in the battery manufacturing process at a supplier. |
| P010031/S233
2/24/11 |
Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry and Maximo II Families of CRT-Ds | Medtronic, Inc.
Mounds View, MN 55112 |
Revision of parameters to an epoxy dispense manufacturing process. |
| P010031/S235
2/23/11 |
Concerto CRT-D, Concerto II ICD, Consulta CRT-D, InSync II Marquis, InSync II Protect, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II CRT-D | Medtronic, Inc. Mounds View, MN 55112 | Automation of an additional plating line. |
| P010047/S008
2/10/11 |
NeoMend ProGel™ Surgical Sealant | NeoMend, Inc. Irvine, CA
92618 |
Packaging of ProGel™ Applicator Spray Tips as an accessory separately from the NeoMend Pleural Air Leak Sealant Device. |
| P020004/S058
2/18/11 |
GORE® EXCLUDER® AAA Endoprosthesis | W.L. Gore & Associates, Inc.
Flagstaff, AZ 86001 |
Automation for crimping gold marker bands. |
| P020024/S031
2/18/11 |
AMPLATZER® Duct Occluder, AMPLATZER® 1800 Delivery and Exchange System | AGA Medical Corporation
Plymouth, MN 55442 |
Use of new patch forming equipment. |
| P020056/S013
2/11/11 |
Natrelle Silicone-Filled Breast Implants | Allergan
Goleta, CA 93117 |
Change in the tubing used in the gel filling process. |
| P030011/S010
2/18/11 |
SynCardia Temporary Total Artificial Heart (TAH-t) System | SynCardia Systems, Inc.
Tuscon, AZ 85713 |
Relocation of several critical manufacturing operations from one building to another within the same corporate complex. |
| P030035/S077
2/23/11 |
Frontier, Frontier II, and Anthem Families of CRT-Ps | St. Jude Medical, Inc.
Sylmar, CA 91342 |
Change to the setscrew and septum installation process. |
| P040014/S016
2/17/11 |
Therapy Cardiac Ablation Catheter | St. Jude Medical, Inc.
Irvine, CA 92614 |
Implementation of an additional test system for electrical testing. |
| P040037/S034
2/16/11 |
Gore VIBAHN® Endoprosthesis | W.L. Gore & Associates, Inc.
Flagstaff, AR 86001 |
Duplication of a manufacturing process at an alternate building within the same complex. |
| P040037/S035
2/18/11 |
Gore VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc.
Flagstaff, AR 86001 |
Duplication of a similar manufacturing process at an alternate location. |
| P040040/S016
2/18/11 |
Amplatzer® Muscular VSD Occluder | AGA Medical Corporation
Plymouth, MN 55442 |
Use of new patch forming equipment. |
| P040042/S021
2/17/11 |
Therapy Dual 8, Therapy and Safire TX Ablation Catheters | St. Jude Medical, Inc.
Irvine, CA 92614 |
Implementation of an additional test system for electrical testing. |
| P050006/S019
2/18/11 |
GORE® HELEX Septal Occluder | W.L. Gore & Associates, Inc.
Flagstaff, AZ 86001 |
Addition of alternate powder for the manufacturing of the Occluder. |
| P050028/S013
2/24/11 |
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 for use with The High Pure System | Roche Molecular Systems, Inc.
Pleasanton, CA 94566 |
Elimination of the in-process chemical testing of the Buffer Concentrate component of the Master Mix used with the COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 within the FDA approved PCR Manufacturing Center (PMC) facility in Branchburg, New Jersey. |
| P050042/S009
2/17/11 |
ARCHITECT Anti-HCV | Abbott Laboratories Abbott Park, IL
60064 |
Change in the vendors for antifoam and goat serum, and a change in a material test method. |
| P050044/S017
2/25/11 |
Vitagel Surgical Hemostat | Orthovita Incorporated
Malvern, PA 19355 |
Addition of an alternate location for conducting two microbiological assays used in the manufacture of the Vitagel Surgical Hemostat. |
| P060002/S017
2/16/11 |
FLAIR® Endovascular Stent Graft | C.R. Bard, Inc. Tempe, AZ
85281 |
Changes to the manufacturing data access and storage software systems. |
| P060019/S017
2/17/11 |
Therapy Cool Path Ablation Catheter | St. Jude Medical, Inc.
Irvine, CA 92614 |
Implementation of an additional test system for electrical testing. |
| P060030/S15
2/24/11 |
COBAS TaqMan HCV Test, v2.0 for use with The High Pure System | Roche Molecular Systems, Inc.
Pleasanton, CA 94566 |
Elimination of the in-process chemical testing of the Buffer Concentrate component of the Master Mix used with the COBAS TaqMan HCV Test, v2.0. |
| P060038/S009
2/3/11 |
Mitroflow® Aortic Pericardial Heart Valve | Sorin Group USA, Inc.
Arvada, CO 80004 |
Addition of a supplier of a device component. |
| P070007/S027
2/7/11 |
Talent Thoracic Stent Graft System | Medtronic Vascular
Santa Rosa, CA 95403 |
Change to sample numbers for Endotoxin Testing and a lot definition change. |
| P070022/S010
2/16/11 |
Adiana Permanent Contraception System | GYN-Surgical Products
Marlborough, MA 01752 |
Change to the work instructions for the fluid filling process of the damper subassembly. |
| P070027/S028
2/7/11 |
Abdominal Stent Graft System | Medtronic Vascular
Santa Rosa, CA 95403 |
Change to sample numbers for Endotoxin Testing and a lot definition change. |
| P100021/S001
2/7/11 |
Endurant Stent Graft System | Medtronic Vascular
Santa Rosa, CA 95403 |
Change to sample numbers for Endotoxin Testing and a lot definition change. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 54
Summary of PMA Originals Under Review
Total Under Review: 97
Total Active: 49
Total On Hold: 48
Number Greater Than 180 Days: 5
Summary of PMA Supplements Under Review
Total Under Review: 681
Total Active: 474
Total On Hold: 207
Number Greater Than 180 Days: 12
Summary of All PMA Submissions Received
Originals: 4
Supplements: 82
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 54
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 173.2
FDA Time: 111.5 Days MFR Time: 61.7 Days
