Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | DEXTRUS STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEADS MODELS 4135,4136 & 4137 |
Generic Name | Pulse generator, permanent, implantable |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S048 |
Date Received | 12/13/2006 |
Decision Date | 03/08/2007 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ADDITIONAL TRADE NAME FOR THE MARKET APPROVED SETROX S LEAD, AS WELL AS MINOR CHANGES TO THE ACCESSORIES, PACKAGING, AND LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXTRUS, AND LABELED FOR DISTRIBUTION BY GUIDANT. THE DEXTRUS LEAD IS INDICATED FOR PERMANENT PACING AND SENSING IN EITHER THE RIGHT ATRIUM OR RIGHT VENTRICLE IN CONJUNCTION WITH IMPLANTABLE PULSE GENERATORS WITH IS-1 HEADERS. |
|
|