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Device | KENTROX RV STEROID AND KENTROX SL STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S018 |
Date Received | 06/14/2004 |
Decision Date | 07/27/2004 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR ADDITION OF THE STEROID COLLAR TO THE DISTAL END OF THE LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME KENTROX SL STEROID AND KENTROX RV STEROID AND IS INDICATED FOR USE IN CONJUNCTION WITH A BIOTRONIK ICD. |