Summary of PMA Originals & Supplements Approved
- Originals: 3
- Supplements: 69
Summary of PMA Originals Under Review
- Total Under Review: 64
- Total Active: 34
- Total On Hold: 30
Summary of PMA Supplements Under Review
- Total Under Review: 509
- Total Active: 374
- Total On Hold: 135
Summary of All PMA Submissions
- Originals: 4
- Supplements: 47
Summary of PMA Supplement PMA Approval/Denial Decision Times
- Number of Approvals: 69
- Number of Denials: 0
- Average Days Fr Receipt to Decision (Total Time): 122.8
- FDA Time: 99.5 Days
- MFR Time: 23.3 Days
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P130019 1/14/15 |
Maestro® Rechargeable System | Enteromedics, Inc. Saint Paul, MN 55113 |
Approval for the Maestro® Rechargeable System. This device is indicated for use in weight reduction in patients aged 18 years through adulthood who have a Body Mass Index (BMI) of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with one or more obesity related co-morbid conditions, and have failed at least one supervised weight management program within the past five years. |
| P130025 1/14/15 |
Koning Breast CT (Model CBCT 1000) | Koning Corporation West Henrietta, NY 14586 |
Approval for the Koning Breast CT (Model CBCT 1000). This device is indicated as follows: Koning Breast CT (CBCT1000) is a cone beam computed tomography system intended to provide three dimensional images for diagnostic imaging of the breast. Koning Breast CT should be read along with standard 2-view mammography (CC and MLO views). |
| P140017 1/27/15 |
Melody™ Transcatheter Pulmonary Valve, Models PB1016 and PB1018, Ensemble™ Transcatheter Valve Delivery System, Models NU1018, NU1020, and NU1022 |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Melody™ Transcatheter Pulmonary Valve (TPV) and the Ensemble™ Transcatheter Valve Delivery System. This device is indicated for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions: 1) Existence of a full (circumferential) right ventricular outflow tract (RVOT) conduit that was equal to or greater than 16 mm in diameter when originally implanted, and 2) Dysfunctional RVOT conduit with a clinical indication for intervention, and: a) regurgitation, ≥ moderate regurgitation and/or; b) stenosis:mean RVOT gradient ≥ 35 mmHg. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P780007/S053 1/9/15 135-Day |
Polymacon Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Approval for a new test method for bioburden enumeration. |
| P860057/S130 1/12/15 Special |
Carpentier-Edwards® PERIMOUNT Pericardial Bioprostheses | Edwards Lifesciences, LLC. Irvine, CA 92614 |
Approval for an additional gluteraldehyde change-out step in the manufacturing process and related manufacturing procedure updates to reflect this new step. |
| P880086/S251 1/13/15 Real-Time |
Assurity, Assurity+, Endurity, Accent Family of Pacemakers | St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for Merlin.net MN5000 v7.2 software used with the devices. |
| P890003/S313 1/26/15 180-Day |
MyCareLink Smart Monitor and the MyCareLink Heart Application | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the MyCareLink Smart Monitor used with the device. The device, as modified, will be marketed under the trade name MyCareLink Smart Monitor and the MyCareLink Heart Application and is indicated for: Patient Reader Indications for Use: The patient reader is a portable electronic device that communicates with the Medtronic implanted heart device. The application on smart phone or tablet transmits implanted heart device data to the Medtronic CareLink Network. Mobile Application Indications for Use: The Medtronic MyCareLink Heart Application transmits implanted heart device data to the CareLink Network via a mobile device. |
| P890023/S021 1/9/15 135-Day |
Ocufilcon D Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Approval for a new test method for bioburden enumeration. |
| P910023/S348 1/13/15 Real-Time |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Epic DR/VR, Epic+ DR/VR Tantalum, Atlas/II/+, DR/VR, Convert, Photon/DR HV, Photon Micro/VR/DR Family of ICDs, Merlin.net MN5000 v7.2 software |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for Merlin.net MN5000 v7.2 software used with the devices. |
| P910023/S351 1/28/15 Real-Time |
Fortify, Fortify DR, Fortify Assura, Assura VR, Fortify Assura DR Family of ICDs | St. Jude Medical Sylmar, CA 91342 |
Approval for modified design of insulating tape. |
| P910077/S148 1/6/15 Real-Time |
LATITUDE Consult System | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the addition of support for the INGENIO 2 family of implantable devices to the LATITUDE Consult System version 1.01. |
| P950029/S096 1/6/15 Real-Time |
Reply SR, Reply DR, Esprit SR, and Esprit DR Pacemakers | Sorin Group Arvada, CO 80004 |
Approval for design changes to and an alternate supplier for the G-Sensor component used in the accelerometer of the Reply and Esprit pacemakers. |
| P960016/S052 1/15/15 Special |
Livewire TC Ablation Catheters | St. Jude Medical Plymouth, MN 55442 |
Approval for the addition of a new effective length inspection. |
| P960040/S336 1/29/15 180-Day |
ORIGEN EL ICD, INOGEN EL ICD, DYNAGEN EL ICD, ORIGEN MINI ICD, INOGEN MINI ICD, DYNAGEN MINI ICD, INCEPTA ICD ENERGEN ICD, PUNCTUA ICD |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval for improvements and modifications to the NG3 and Progeny ICD and CRT-D devices. |
| P960040/S337 1/6/15 Real-Time |
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, and AUTOGEN Families of ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the addition of support for the INGENIO 2 family of implantable devices to the LATITUDE Consult System version 1.01. |
| P960043/S089 1/20/15 Real-Time |
Perclose ProGlide Suture Mediated Closure System, Perclose AT Suture Mediated Closure System |
Abbott Vascular Inc. Temecula, CA 92589 |
Approval for modifying the angle tolerance of the plunger component. |
| N970003/S169 1/6/15 Real-Time |
ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, and ALTRUA 2 Families of Pacemakers |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the addition of support for the INGENIO 2 family of implantable devices to the LATITUDE Consult System version 1.01. |
| N970012/S102 1/28/15 Real-Time |
AMS 700™ Inflatable Penile Prosthesis | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for the use of (i) the zone of inhibition (ZOI) as the shelf life indication factor and to consistently use (ii) a two year shelf life for InhibiZone® (IZ) treated devices. The devices, as modified, will be marketed under the trade name AMS 800™ Artificial Urinary Sphincter (AMS 800). The device is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 700™ Inflatable Penile Prosthesis (AMS 700) is used in the treatment of chronic, male erectile dysfunction (impotence). |
| P980016/S492 1/26/15 180-Day |
Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Entrust, Intrinsic 30, Intrinsic, Marquis DR, Marquis VR, Maximo DR, Maximo II, Maximo VR, Protecta, Protecta XT, Secura, Virtuoso DR/VR, and Virtuoso II DR/VR Family of ICDs |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the MyCareLink Smart Monitor used with the device. The device, as modified, will be marketed under the trade name MyCareLink Smart Monitor and the MyCareLink Heart Application and is indicated for: Patient Reader Indications for Use: The patient reader is a portable electronic device that communicates with the Medtronic implanted heart device. The application on smart phone or tablet transmits implanted heart device data to the Medtronic CareLink Network. Mobile Application Indications for Use: The Medtronic MyCareLink Heart Application transmits implanted heart device data to the CareLink Network via a mobile device. |
| P980016/S513 1/30/15 Real-Time |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD | Medtronic Incorporated Mounds View, MN 55112 |
Approval for a minor design tolerance change and associated inspection procedure changes for multipolar feedthrough insulators for selected implantable cardioverter defibrillators and cardiac resynchronization therapy-defibrillators. |
| P980022/S167 1/29/15 Real-Time |
Paradigm REAL-Time, Paradigm REAL-Time Revel, Guardian REAL-Time, MiniLink REAL-Time, iPro2 Professional CGM Systems |
Medtronic MiniMed Northridge, CA 91325 |
Approval for use of a thicker double-sided tape on the Sof-Sensor (Model MMT-7002, MMT-7003 and Enlite sensor (MMT-7008) base as well as change in the converter/distributor of the tape. The Sof-Sensor (Model MMT-7002, MMT-7003) is a component of the Paradigm REAL-Time, Paradigm REAL-Time Revel, Guardian REAL-Time, MiniLink REAL-Time, and iPro2 Professional CGM Systems and the Enlite Glucose Sensor (MMT-7008) is a component of the MiniMed 530G System. |
| P980022/S168 1/28/15 Real-Time |
Guardian REAL-time Continuous Glucose Monitoring Systems | Medtronic MiniMed Northridge, CA 91325 |
Approval for an alternate super capacitor, a component used on the Interface Boards of the Guardian REAL-time Monitors (Models CSS7100 and CSS7100K) which are components of the Guardian REAL-time Continuous Glucose Monitoring System. |
| P980035/S384 1/26/15 180-Day |
Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, EnRhythm, EnPulse E1, EnPulse E2, Kappa D, Kappa DR, Kappa SR, and Kappa VDD Family of IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the MyCareLink Smart Monitor used with the device. The device, as modified, will be marketed under the trade name MyCareLink Smart Monitor and the MyCareLink Heart Application and is indicated for: Patient Reader Indications for Use: The patient reader is a portable electronic device that communicates with the Medtronic implanted heart device. The application on smart phone or tablet transmits implanted heart device data to the Medtronic CareLink Network. Mobile Application Indications for Use: The Medtronic MyCareLink Heart Application transmits implanted heart device data to the CareLink Network via a mobile device. |
| P000025/S079 1/20/15 180-Day |
MED-EL Cochlear Implant System | MED-EL Corporation Durham, NC 27713 |
Approval for the Mi1200 SYNCHRONY and Mi1200 SYNCHRONY PIN Cochlear Implants, each with electrode variants +standard, +medium, +compressed, GB, +FLEX24, +FLEX28, associated Surgical Tools, replacement implant magnet and non-magnetic spacer, and compatible magnets for external components. |
| P000053/S053 1/28/15 Real-Time |
AMS 800™ Urinary Control System | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for the use of (i) the zone of inhibition (ZOI) as the shelf life indication factor and to consistently use (ii) a two year shelf life for InhibiZone® (IZ) treated devices. The devices, as modified, will be marketed under the trade name AMS 800™ Artificial Urinary Sphincter (AMS 800). The device is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 700™ Inflatable Penile Prosthesis (AMS 700) is used in the treatment of chronic, male erectile dysfunction (impotence). |
| P000058/S058 1/27/15 Real-Time |
INFUSE® Bone Graft/LT-CAGE® Lumbar Tapered Fusion Device | Medtronic Spinal and Biologics Memphis, TN 38132 |
Approval for modifications to the package insert and patient information brochure (modification of this document was subsequently withdrawn) as follows: 1) addition of Warning and Precaution language related to data generated from the cervical spine study; 2) clarification to the posterior bone formation precaution; 3) revision to the retrograde ejaculation Warning language; 4) organization of the Warnings into similar groups of issues; 5) replacement of “ectopic bone formation” with “heterotopic ossification”; 6) addition of several additional Potential Adverse Events; and 7) alphabetization of the Potential Adverse Events. |
| P010012/S376 1/29/15 180-Day |
DYNAGEN CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D, INCEPTA CRT-D, ENERGEN CRT-D, PUNCTUA CRT-D |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval for improvements and modifications to the NG3 and Progeny ICD and CRT-D devices. |
| P010012/S377 1/6/15 Real-Time |
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, and AUTOGEN Families of CRT-Ds |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the addition of support for the INGENIO 2 family of implantable devices to the LATITUDE Consult System version 1.01. |
| P010012/S380 1/21/15 Real-Time |
EASYTRAK 2 IS-1 Coronary Venous Steroid-Eluting Dual Electrode Pace/Sense Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for an addition of Silglide coating to the outer distal silicone body tubing to ease delivery through an inner catheter 7 French and associated label changes to rebrand the lead as Easytrak 2+. |
| P010015/S244 1/26/15 180-Day |
Consulta CRT-P, Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the MyCareLink Smart Monitor used with the device. The device, as modified, will be marketed under the trade name MyCareLink Smart Monitor and the MyCareLink Heart Application and is indicated for: Patient Reader Indications for Use: The patient reader is a portable electronic device that communicates with the Medtronic implanted heart device. The application on smart phone or tablet transmits implanted heart device data to the Medtronic CareLink Network. Mobile Application Indications for Use: The Medtronic MyCareLink Heart Application transmits implanted heart device data to the CareLink Network via a mobile device. |
| P010031/S455 1/26/15 180-Day |
Brava CRT-D, Concerto ICD, Concerto II CRT-D, Consulta ICD, InSync II Protect ICD, InSync III Marquis ICD, InSync Maximo ICD, InSync Marquis, InSync Sentry, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the MyCareLink Smart Monitor used with the device. The device, as modified, will be marketed under the trade name MyCareLink Smart Monitor and the MyCareLink Heart Application and is indicated for: Patient Reader Indications for Use: The patient reader is a portable electronic device that communicates with the Medtronic implanted heart device. The application on smart phone or tablet transmits implanted heart device data to the Medtronic CareLink Network. Mobile Application Indications for Use: The Medtronic MyCareLink Heart Application transmits implanted heart device data to the CareLink Network via a mobile device. |
| P010031/S477 1/30/15 Real-Time |
Brava CRT-D, Brava Quad CRT-D, Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic Incorporated Mounds View, MN 55112 |
Approval for a minor design tolerance change and associated inspection procedure changes for multipolar feedthrough insulators for selected implantable cardioverter defibrillators and cardiac resynchronization therapy-defibrillators. |
| P020002/S009 1/12/15 Real-Time |
ThinPrep Imaging System | Hologic, Inc. Marlborough, MA 01752 |
Approval for modifications to the Review Scope Manual Plus microscope frame of the ThinPrep Imaging System. |
| P020050/S018 1/20/15 Real-Time |
WaveLight EX500 Excimer Laser System | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for a new software release for the WaveLight® EX500 Excimer Laser System. |
| P020056/S029 1/16/15 180-Day |
Silicone Gel-Filled Breast Implant | Allergan, Inc. Santa Barbara, CA 93111 |
Approval of the following changes to the post-approval study for the device: Re-Op Phase protocol as a new post-approval study requirement. |
| P030005/S115 1/6/15 Real-Time |
INVIVE, INLIVEN, INTUA, VALITUDE, and VALITUDE X4 Families of CRT-Ps |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the addition of support for the INGENIO 2 family of implantable devices to the LATITUDE Consult System version 1.01. |
| P030008/S016 1/20/15 Real-Time |
WaveLight EX500 Excimer Laser System | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for a new software release for the WaveLight® EX500 Excimer Laser System. |
| P030035/S129 1/13/15 Real-Time |
Anthem, Allure/RF, Allure Quadra/RF Family of CRT-Ps | St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for Merlin.net MN5000 v7.2 software used with the devices. |
| P030050/S022 1/6/15 135-Day |
Sculptra and Sculptra Aesthetic | Galderma Laboratories, L.P. Fort Worth, TX 76177 |
Approval for a new autoclave. |
| P030053/S019 1/16/15 180-Day |
MemoryGel Silicone Gel-Filled Breast Implants | Mentor Worldwide LLC Santa Barbara, CA 93111 |
Approval of the following changes to the post-approval study for the device: Re-Op Phase protocol as a new post-approval study requirement. |
| P030054/S278 1/13/15 Real-Time |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ HF, Atlas+HF/II HH/II+ HF, Atlas DR/VR Family of CRT-Ds |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for Merlin.net MN5000 v7.2 software used with the devices. |
| P030054/S280 1/28/15 Real-Time |
Unify, Unify Assura, Unify Quadra, Quadra Assura Family of CRT-Ds | St. Jude Medical Sylmar, CA 91342 |
Approval for modified design of insulating tape. |
| P040037/S074 1/8/15 Real-Time |
GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface |
W.L. Gore & Associates, Inc. Flagstaff, AZ 86005 |
Approval for the addition of a 7.5 cm endoprosthesis length in 5-8 mm and 9 mm diameter configurations, with and without heparin, on both the 0.035” guidewire catheter (75cm and 120cm length) and the 0.014”/0.018” guidewire catheter (120cm length). |
| P050017/S009 1/7/15 180-Day |
Zilver Vascular Stent | Cook Medical, Incorporated Bloomington, IN 47402 |
Approval for a manufacturing site located at Norman Noble, Inc., Highland Heights, Ohio. |
| P050034/S015 1/27/15 180-Day |
Implantable Miniature Telescope (IMT) | Vision Care Ophthalmic Technologies, Ltd. Saratoga, CA 95070 |
Approval of the following changes to the post-approval study protocol: updated study protocol with the inclusion of Case Report Form (CRF) and study timeline. |
| P050052/S052 1/30/15 180-Day |
Radiesse® (+) | Merz North America Incorporated Franksville, WI 53126 |
Approval for modification to the formulation, syringe material, specifications, manufacturing process and labeling to support the addition of the lidocaine and improve manufacturing efficacy. The device as modified will be marketed under the trade name, Radiesse® (+) and is indicated for sub-dermal implantation the correction of moderate to severe facial folds and wrinkles, including nasolabial folds. |
| P060001/S020 1/21/15 Panel-Track |
Protégé™ GPS Self-Expanding Peripheral Stent System | ev3, Inc. Plymouth, MN 55441 |
Approval for the Protégé™ GPS Self-Expanding Peripheral Stent System. This device is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to and including 100 mm in length, with a reference vessel diameter of 7.5 – 11 mm. |
| P070026/S023 1/30/15 135-Day |
Ceramax Ceramic Total Hip System | DePuy Orthopedics, Inc. Warsaw, IN 46581 |
Approval for the relocation of manufacturing processes . |
| P080011/S028 1/9/15 135-Day |
Comfilcon A Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Approval for a new test method for bioburden enumeration. |
| P090012/S008 1/26/15 135-Day |
MelaFind Cart, Hand-Held Imager | MELA Sciences Incorporated Irvington, NY 10533 |
Approval for changes to the test procedures for the Hand held cart assembly; deployment of new software and installation workstations and an update for the Hand held test method. |
| P090013/S149 1/26/15 180-Day |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the MyCareLink Smart Monitor used with the device. The device, as modified, will be marketed under the trade name MyCareLink Smart Monitor and the MyCareLink Heart Application and is indicated for: Patient Reader Indications for Use: The patient reader is a portable electronic device that communicates with the Medtronic implanted heart device. The application on smart phone or tablet transmits implanted heart device data to the Medtronic CareLink Network. Mobile Application Indications for Use: The Medtronic MyCareLink Heart Application transmits implanted heart device data to the CareLink Network via a mobile device. |
| P100014/S017 1/21/15 180-Day |
Solesta® | Salix Pharmaceuticals, Inc. Raleigh, NC 27615 |
Approval for patient labeling changes. |
| P100018/S011 1/26/15 180-Day |
Pipeline™ Flex Embolization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Irvine, CA 92618 |
Approval for design changes to the delivery system of the Pipeline™ Embolization System. The device, as modified, will be marketed under the trade name, Pipeline™ Flex Embolization Device (PFED), and remains indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. |
| P100021/S041 1/22/15 Real-Time |
Endurant and Endurant II Stent Graft Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for revision of the delivery system graft cover tensile specification. |
| P100022/S010 1/7/15 180-Day |
Zilver PTX Drug Eluting Peripheral Stent | Cook Medical, Incorporated Bloomington, IN 47402 |
Approval for a manufacturing site located at Norman Noble, Inc., Highland Heights, Ohio. |
| P100022/S011 1/13/15 180-Day |
Zilver PTX Drug-Eluting Peripheral Stent | Cook Medical, Inc. Bloomington, IN 47402 |
Approval to the post-approval study for the device to allow for enrollment of Japanese PMS patients with lesion length up to 200 mm per limb is complete. |
| P100023/S104 1/21/15 180-Day |
Ion Paclitaxel-Eluting Coronary Stent System (Monorail and Over- The-Wire Systems) |
Boston Scientific, Corp. Maple Grove, MN 55311 |
Approval for a revised labeling update for the TAXUS PERSEUS Workhorse (WH) and Small Vessel (SV) 5-Year Study per Post-Approval Commitment #1. |
| P100023/S112 1/15/15 180-Day |
ION Paclitaxei-Eiuting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a manufacturing site located in Maple Grove, Minnesota. |
| P100049/S011 1/21/15 180-Day |
Linx Reflux Management System | Torax Medical, Inc. Shoreview, MN 55126 |
Approval for modifications to the internal magnets and wire links connecting the beads, as well as associated modifications to the labeling, allowing the device to be Magnetic Resonance (MR) Conditional up to 1.5 Tesla. |
| P110010/S101 1/15/15 180-Day |
PROMUS Element Plus and PROMUS Premier Everolimus-Eiuting Platinum Chromium Coronary Stent System |
Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a manufacturing site located in Maple Grove, Minnesota. |
| P110016/S013 1/23/15 180-Day |
FlexAbility Ablation Catheter | St. Jude Medical St. Paul, MN 55117 |
Approval for the FlexAbility Ablation Catheter to be manufactured at St. Jude Medical in Plymouth, Minnesota. The device, as modified, will be marketed under the trade name FlexAbility Ablation Catheter and is indicated for use with the compatible irrigation pump and a compatible RF cardiac ablation generator. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping stimulation, and ablation) for the treatment of typical atrial flutter. |
| P110033/S011 1/27/15 135-Day |
Juvederm Voluma XC | Allergan Goleta, CA 93117 |
Approval to transfer modified hyaluronic acid testing in-house from a contract facility. |
| P120005/S028 1/23/15 180-Day |
Dexcom G4 Platinum Continuous Glucose Monitoring System, Dexcom G4 Platinum Pediatric Continuous Glucose Monitoring System, Dexcom SHARE System |
Dexcom, Inc. San Diego, CA 92121 |
Approval for the addition of a Bluetooth Low Energy (BLE) radio to both the adult (MT20649) and pediatric (MT22430) versions of the Dexcom G4 Platinum receiver, identified as the Dexcom G4 Platinum Receiver with Share (adult – MT22495, pediatric – MT22608), and for a modification to the Dexcom Share System (STA-GL-400) allowing the Dexcom G4 Platinum Receiver with Share to communicate directly with the Dexcom Share2 mobile application installed on a user’s Apple mobile device. The Dexcom Receiver with Share is a component of the Dexcom G4 Platinum Continuous Glucose Monitoring System, the Dexcom G4 Platinum Pediatric Continuous Glucose Monitoring System, and the Dexcom SHARE System. Though the indications for use for the Dexcom G4 Platinum Continuous Glucose Monitoring System and the Dexcom G4 Platinum Pediatric Continuous Glucose Monitoring System are unchanged by this supplement, the Dexcom Share System, as modified, will be marketed under the trade name Dexcom SHARE System and is indicated for: The purpose of Dexcom SHARE is to notify another person, the Follower, of the patient’s Dexcom G4 PLATINUM Continuous Glucose Monitoring System sensor glucose information. Dexcom Share provides secondary notification and does not replace real time continuous glucose monitoring (G4 PLATINUM System) or standard home blood glucose monitoring. |
| P120006/S017 1/14/15 Real-Time |
Ovation and Ovation Prime Abdominal Stent Graft Systems | Trivascular, Inc. Santa Rosa, CA 95403 |
Approval for a modification to the CustomSeal Kit. |
| P120010/S041 1/28/15 Real-Time |
MiniMed 530G System | Medtronic Minimed Northridge, CA 91325 |
Approval for minor design changes to the sensor base, O-ring, tape, adhesive and sensor patch of the Enlite glucose sensor (MMT-7008A, MMT-7008B) in order to support manufacturing changes from a manual assembly process to an automated assembly line for the Enlite glucose sensor. The Enlite glucose sensor is a component of the MiniMed 530G System. |
| P120010/S042 1/29/15 Real-Time |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Approval for use of a thicker double-sided tape on the Sof-Sensor (Model MMT-7002, MMT-7003 and Enlite sensor (MMT-7008) base as well as change in the converter/distributor of the tape. The Sof-Sensor (Model MMT-7002, MMT-7003) is a component of the Paradigm REAL-Time, Paradigm REAL-Time Revel, Guardian REAL-Time, MiniLink REAL-Time, and iPro2 Professional CGM Systems and the Enlite Glucose Sensor (MMT-7008) is a component of the MiniMed 530G System. |
| P120014/S001 1/30/15 135-Day |
THxID™ -BRAF kit | BioMerieux, Inc. Hazelwood, MO 63042 |
Approval for a new determination method of plasmids and transcripts concentration during the manufacturing step (FGM/POL/ M00454), by using NanoDrop UV-Vis spectrophotometer to change from the old method utilizing standard UV-Vis spectrophotometer. |
| P120016/S005 1/12/15 135-Day |
Vascade Vascular Closure System | Cardiva Medical, Inc. Sunnyvale, CA 94085 |
Approval for a change to the Chronoprene membrane and Cut- tolength equipment. |
| P120020/S006 1/9/15 180-Day |
Supera Peripheral Stent System | Abbott Vascular Santa Clara, CA 95054 |
Approval for a manufacturing site located at Abbott Vascular, in Temecula, California. |
| P130006/S014 1/8/15 Real-Time |
GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface |
W.L. Gore & Associates, Inc. Flagstaff, AZ 86005 |
Approval for the addition of a 7.5 cm endoprosthesis length in 5-8 mm and 9 mm diameter configurations, with and without heparin, on both the 0.035” guidewire catheter (75cm and 120cm length) and the 0.014”/0.018” guidewire catheter (120cm length). |
| P130024/S001 1/22/15 Real-Time |
Lutonix Drug Coated Balloon (DCB) | Lutonix, Inc. New Hope, MN 55428 |
Approval for a change in balloon protector from a slide-off to a peelaway design. |
| P130030/S007 1/14/15 180-Day |
REBEL Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a manufacturing site located in Maple Grove, Minnesota. |
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 |
|---|---|---|---|
| N18033/S075 1/22/15 |
Vistakon (senofilcon A) and (etafilcon A) brand contact lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Enhancement of in-process control point lens sensor for the Vistakon (senofilcon A) and (etafilcon A) brand contact lenses. |
| P830055/S154 1/21/15 |
LCS Total Knee System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Change a manufacturing step from a manual process to an automated process. |
| P840001/S287 1/16/14 |
Restore Patient Programmer, Restore Charging System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Add two additional device models to a previous change in new material on the integrated circuit components used in the device. |
| P860057/S131 1/30/15 |
Carpentier-Edwards Perimount Pericardial Bioprostheses | Edwards Lifesciences, LLC. Irvine, CA 92614 |
New bovine tissue supplier. |
| P890055/S059 1/15/15 |
Codman 3000 Series Constant Flow Implantable Infusion Pump | Codman and Shutleff, Incorporated Raynham, MA 02767 |
Installation of a new package sealer. |
| P910001/S075 1/7/15 |
ELCA Coronary Atherectomy Catheters | Spectranetics Corp. Colorado Springs, CO 80921 |
Change to the distal jacket fuse process. |
| P910001/S076 1/8/15 |
Spectranetics Excimer Coronary Laser Artherectomy (ECLA) Catheters | The Spectranetics Corporation Colorado Springs, CO 80921 |
Change to automate the pin cutting process on the proximal handle which is currently performed manually. |
| P930039/S122 1/6/15 |
Capsurefix Novus and Vitatron Crystalline Active Fixation Leads | Medtronic, Inc. Mounds View, MN 55112 |
Updates to the parameters of the plasma treatment process used for the silicone tubing component. |
| P960040/S340 1/9/15 |
ORIGEN, INOGEN, DYNAGEN ICDs | Boston Scientific Corporation Saint Paul, MN 55112 |
Additional supplier for the power inductors used in the devices. |
| P960040/S341 1/6/15 |
DYNAGEN CRT-Ds, INOGEN CRT-Ds, ORIGEN CRT-Ds |
Boston Scientific Corporation Saint Paul, MN 55112 |
Add an alternate supplier for the transformer used in the high voltage circuit in the devices. |
| P960042/S051 1/8/15 |
Spectranetics Excimer Coronary Laser Artherectomy (ECLA) Catheters | The Spectranetics Corporation Colorado Springs, CO 80921 |
Change to automate the pin cutting process on the proximal handle which is currently performed manually. |
| P970051/S127 1/23/15 |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Eight changes to the bioburden monitoring and processing. |
| P980016/S515 1/21/15 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD | Medtronic CRDM Mounds View, MN 55112 |
Update to the sputter mask used on the feedthrough insulators as well the addition of a second source supplier for the feedthrough insulator. |
| P980022/S174 1/2/15 |
Paradigm REAL‐Time System, Paradigm REAL‐Time Revel System, Guardian Real‐Time System MiniLink, REAL‐Time System |
Medtronic Minimed Northridge, CA 91325 |
Implementation of a new tool used at a contract manufacturer to support the back end testing of the assembled MiniLink REAL-Time Transmitter (MMT-7703). The MiniLink Transmitter is a component of the Paradigm REAL‐Time System, Paradigm REAL‐Time Revel System, Guardian Real‐Time System, MiniLink REAL‐Time System, as well as the MiniMed 530G System. |
| P980022/S175 1/14/15 |
Paradigm Real-Time System Paradigm Real-Time Revel System |
Medtronic MiniMed Northridge, CA 91325 |
A change in tertiary suppliers and method for the nickel and gold plating process for the keypad flexible circuit for the Paradigm Real-Time Insulin Pump (MMT-522, MMT-522k, MMT-722, MMT-722k), Paradigm Real-Time Revel Insulin Pump (MMT-523, MMT-523k, MMT-723, MMT-723k) and MiniMed 530G Insulin Pump (MMT-551, MMT-751) that are part of the Paradigm Real-Time System, the Paradigm Real-Time Revel System and the MiniMed 530G System, respectively. |
| P000006/S039 1/7/15 |
Titan Inflatable Penile Prosthesis | Coloplast Corp Minneapolis, MN 55411 |
Implementing use of an additional piece of equipment. |
| P000012/S051 1/14/15 |
COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/COBAS® AMPLICOR® HCV Test version 2.0 | Roche Molecular Systems, Incorporated Pleasanton, CA 94588 |
Relocation of instruments used for functional testing of components and finished devices to a new laboratory within the same manufacturing facility at Penzberg, Germany. |
| P000012/S052 1/15/15 |
COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/COBAS® AMPLICOR® HCV Test version 2.0 |
Roche Molecular Systems, Incorporated Pleasanton, CA 94588 |
Change to the HPLC system qualification retention time window for the purification of an oligonucleotide. |
| P010012/S381 1/9/15 |
ORIGEN, INOGEN, DYNAGEN CRT-Ds |
Boston Scientific Corporation Saint Paul, MN 55112 |
Additional supplier for the power inductors used in the devices. |
| P010012/S382 1/6/15 |
DYNAGEN ICDs, INOGEN ICDs, ORIGEN ICDs |
Boston Scientific Corporation Saint Paul, MN 55112 |
Add an alternate supplier for the transformer used in the high voltage circuit in the devices. |
| P010029/S021 1/21/15 |
EUFLEXXA (1% Sodium Hyaluronate) | Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054 |
Proposed revised stability protocol. |
| P010031/S479 1/21/15 |
Brava CRT-D, Brava Quad CRT-D, Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic CRDM Mounds View, MN 55112 |
Update to the sputter mask used on the feedthrough insulators as well the addition of a second source supplier for the feedthrough insulator. |
| P020004/S110 1/22/15 |
GORE EXCLUDER AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Implementation of modified thermal processing parameters for the Ultra Thin Wall basetube graft component. |
| P020025/S066 1/15/15 |
IntellaTip MiFi XP Temperature Ablation Catheters | Boston Scientific Corporation San Jose, CA 95134 |
Acceptance of manufacturing changes consisting of a new fixture and in-process testing equipment for the IntellaTip MiFi XP Temperature Ablation Catheters. |
| P030017/S211 1/21/15 |
Precision Spectra Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Valencia, CA 91355 |
Moving Contact Paddle Lead manufacturing processes to a Boston Scientific facility. |
| P030053/S023 1/13/15 |
Mentor MemoryGel Silicone Gel-Filled Breast Implants | MENTOR Worldwide LLC Somerville, NJ 08876 |
Change to provide for a new Gel Fill Pump System used in the manufacture of MENTOR MemoryGel Breast Implants at Mentor’s Irving, Texas Facility. |
| P0400027/S039 1/6/15 |
GORE VIATORR TIPS Endoprosthesis | W.L. Gore & Associates, Inc. Phoenix, AZ 85085 |
Alternate resin for manufacture of the base tube components. |
| P040043/S071 1/22/15 |
GORE TAG Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Implementation of modified thermal processing parameters for the Ultra Thin Wall basetube graft component. |
| P040044/S060 1/9/15 |
Mynx Ace Vascular Closure Device | Access Closure, Inc. Santa Clara, CA 95054 |
Implement a rework step to reload the hydrogel in the Mynx Ace device (model MX6740). |
| P040044/S061 1/9/15 |
Mynx Vascular Closure Device Product Family | Access Closure, Inc. Santa Clara, CA 95054 |
Implement a 12-tray Cold Plate System for hydrogel manufacturing. |
| P040045/S048 1/16/15 |
Vistakon® (senofilcon A) Brand Contact | Johnson and Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Addition of an alternate supplier for the senofilcon A monomer used for manufacturing of VISTAKON® (senofilcon A) brand contact lenses. |
| P040045/S049 1/22/15 |
Vistakon (senofilcon A) and (etafilcon A) brand contact lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Enhancement of in-process control point lens sensor for the Vistakon (senofilcon A) and (etafilcon A) brand contact lenses. |
| P050028/S043 1/14/15 |
COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test version 2.0 | Roche Molecular Systems, Incorporated Pleasanton, CA 94588 |
Relocation of instruments used for functional testing of components and finished devices to a new laboratory within the same manufacturing facility at Penzberg, Germany. |
| P060030/S044 1/14/15 |
COBAS® AmpliPrep/COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test version 2.0 For Use With The High Pure System | Roche Molecular Systems, Incorporated Pleasanton, CA 94588 |
Relocation of instruments used for functional testing of components and finished devices to a new laboratory within the same manufacturing facility at Penzberg, Germany. |
| P060038/S022 1/21/15 |
Mitroflow Aortic Pericardial Heart Valve | Sorin Group Canada, Inc. Burnaby, BC Canada V5J 5M1 |
Change to the incoming quality control inspection for the octanediol solution. |
| P080011/S033 1/21/15 |
CooperVision (comfilcon A) soft, extended-wear contact lenses | CooperVision Inc. Pleasanton, CA 94588 |
Add a new manufacturing line for Biofinity (comfilcon A) extended-wear contact lenses at the CooperVision, Hamble facility, United Kingdom. |
| P080011/S034 1/25/15 |
CooperVision (comfilcon A) Soft, Extended-Wear Contact Lenses | CooperVision Inc. Pleasanton, CA 94588 |
Change to the frequency of water content testing for the comfilcon A soft, extended-wear contact lenses. |
| P080027/S019 1/28/15 |
OraQuick® HCV Rapid Antibody Test | OraSure Technologies, Incorporated Bethlehem, PA 18015 |
Change to the reagent dispensing system used in the manufacture of the device. |
| P090018/S028 1/30/15 |
Esteem System | Envoy Medical Corporation St. Paul, MN 55110 |
New supplier for the header component of the Sound Processor. |
| P090022/S024 1/15/15 |
Softec HD, Softec I, Softec HD PS, and Softec HDO IOLs | Lenstec Inc. St. Petersburg, FL 33716 |
Notification of an additional Rotlex Iola Plus lens analyzer used during the manufacturing process. |
| P100026/S027 1/16/15 |
Neuropace RNS System | NeuroPace, Inc. Mountain View, CA 94043 |
Modify the quality control test for the telemetry coil. |
| P100033/S002 1/21/15 |
Progensa PCA3 Assay | Hologic, Inc. San Diego, CA 92121 |
Manufacturing scale up of the selection reagent used in the Progensa PCA3 Assay. |
| P100041/S062 1/30/15 |
Edwards Sapien Transcatheter Heart Valve | Edwards Lifesciences, LLC. Irvine, CA 92614 |
New bovine tissue supplier. |
| P110011/S008 1/6/15 |
Assurant® Cobalt Iliac Balloon-Expandable Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Change to the routine sterilization dose audits. |
| P110020/S012 1/15/15 |
cobas® 4800 BRAF V600 Mutation Test | Roche Molecular Systems, Incorporated Pleasanton, CA 94588 |
Change to the HPLC system qualification retention time window for the purification of an oligonucleotide. |
| P110021/S049 1/30/15 |
Edwards Sapien Transcatheter Heart Valve | Edwards Lifesciences, LLC. Irvine, CA 92614 |
New bovine tissue supplier. |
| P110027/S002 1/15/15 |
therascreen® KRAS RGQ PCR Kit | QIAGEN Manchester Ltd. Manchester, United Kingdom M15 6SH |
Relocation of the Quality Control laboratories within QIAGEN Manchester Ltd. Skeleton House facility. |
| P110027/S003 1/16/15 |
therascreen KRAS RGQ PCR Kit | QIAGEN Manchester Ltd. Manchester, United Kingdom M15 6SH |
Change to the supplier’s purity testing method for the Internal Control template in the therascreen KRAS RGQ PCR Kit. The new purity testing will use Reversed Phase-Ultra Performance Liquid Chromatography (RP-UPLC) with a change in acceptance criterion from ≥90% to ≥80%. |
| P110037/S017 1/14/15 |
COBAS® AmpliPrep/COBAS® TaqMan® CMV Test | Roche Molecular Systems, Incorporated Pleasanton, CA 94588 |
Relocation of instruments used for functional testing of components and finished devices to a new laboratory within the same manufacturing facility at Penzberg, Germany. |
| P110037/S018 1/15/15 |
COBAS® AmpliPrep/COBAS® Taqman® CMV Test | Roche Molecular Systems, Incorporated Pleasanton, CA 94588 |
Change to the HPLC system qualification retention time window for the purification of an oligonucleotide. |
| P120005/S032 1/22/15 |
Dexcom G4™ PLATINUM Continuous Glucose Monitoring System | Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 |
Change to the manufacturing of the sensor component adhesive patch to support peel adhesion test specifications. The sensor is a component of the G4 Platinum Continuous Glucose Monitoring System. |
| P120009/S002 1/21/15 |
NIT-Occlud System | Pfm Medical Carlsbad, CA 92008 |
Addition of a new piece of equipment for a manufacturing process involving coiling of wire. |
| P120010/S049 1/2/15 |
MiniMed 530G System | Medtronic Minimed Northridge, CA 91325 |
Implementation of a new tool used at a contract manufacturer to support the back end testing of the assembled MiniLink REAL-Time Transmitter (MMT-7703). The MiniLink Transmitter is a component of the Paradigm REAL‐Time System, Paradigm REAL‐Time Revel System, Guardian Real‐Time System, MiniLink REAL‐Time System, as well as the MiniMed 530G System. |
| P120010/S050 1/7/15 |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Increase to the laser cutting speed of the Resonetics Galvo Laser System used in the sensor fabrication process for the Enlite Sensor. The Enlite Sensor is a component of the MiniMed 530G System. |
| P120010/S051 1/14/15 |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
A change in tertiary suppliers and method for the nickel and gold plating process for the keypad flexible circuit for the Paradigm Real-Time Insulin Pump (MMT-522, MMT-522k, MMT-722, MMT-722k), Paradigm Real-Time Revel Insulin Pump (MMT-523, MMT-523k, MMT-723, MMT-723k) and MiniMed 530G Insulin Pump (MMT-551, MMT-751) that are part of the Paradigm Real-Time System, the Paradigm Real-Time Revel System and the MiniMed 530G System, respectively. |
| P120010/S053 1/29/15 |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Change to the glucose oxidase coating volume during the Enlite glucose sensor (MMT-7008) fabrication step. The Enlite glucose sensor is a component of the MiniMed 530G System. |
| P120010 /S055 1/30/15 |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Removal of two engineering process level specifications for a manufacturing step in the Enlite sensor assembly. The Enlite sensor is a component of the MiniMed 530G System. |
| P120016/S008 1/9/15 |
VASCADE™ Vascular Closure System (VCS) | Cardiva Medical, Inc. Sunnyvale, CA 94085 |
A`ddition of a pouch sealer and associated processes to facilitate packaging. |
| P120019/S005 1/15/15 |
cobas® EGFR Mutation Test | Roche Molecular Systems, Incorporated Pleasanton, CA 94588 |
Change to the HPLC system qualification retention time window for the purification of an oligonucleotide. |
| P120022/S004 1/15/15 |
therascreen® EGFR RGQ PCR Kit | QIAGEN Manchester Ltd. Manchester, United Kingdom M15 6SH |
Relocation of the Quality Control laboratories within QIAGEN Manchester Ltd. Skeleton House facility. |
| P120022/S005 1/16/15 |
therascreen EGFR RGQ PCR Kit | QIAGEN Manchester Ltd. Manchester, United Kingdom M15 6SH |
Change to the supplier’s purity testing method for the Internal Control template in the therascreen EGFR RGQ PCR Kit. The new purity testing will use Reversed Phase-Ultra Performance Liquid Chromatography (RP-UPLC) with a change in acceptance criterion from ≥90% to ≥80%. |
| P130009/S022 1/30/15 |
Edwards Sapien XT Transcatheter Heart Valve | Edwards Lifesciences, LLC. Irvine, CA 92614 |
New bovine tissue supplier. |
| P130016/S010 1/23/15 |
Nucleus 24 Hybrid System | Cochlear Americas Centennial, CO 80111 |
Eight changes to the bioburden monitoring and processing. |
| P130030/S008 1/15/15 |
REBEL Monorail and Over-the-Wire Platinum Chromium Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Add an additional coating machine. |
| P140010/S001 1/29/15 |
IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter | Medtronic, Inc. Santa Rosa, CA 95403 |
Change in the dispense handle for the drug coating. |
