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. |
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Device | KENTROX SL ICD LEADS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S016 |
Date Received | 09/15/2003 |
Decision Date | 03/12/2004 |
Product Code |
LWS |
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 CHANGES IN COMPONENT DIMENSIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME KENTROX SL AND IS INDICATED FOR USE IN CONJUNCTION WITH A BIOTRONIK ICD. CURRENTLY, DATA IS NOT AVAILABLE REGARDING THE USE OF THIS LEAD SYSTEM WITH ICDS OF OTHER MANUFACTURERS. USE OF OTHER ICDS MAY ADVERSELY AFFECT SENSING AND/OR THERAPY DELIVERY. |
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