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Device | LINOX SD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S020 |
Date Received | 09/06/2005 |
Decision Date | 01/27/2006 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE LINOX SD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS |