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 | KAINOX VCS, LINOX S/T/SD/TD, KENTROX SL-S/RV-S/SL/RV STEROID, LINOX(SMART) ST/TD LEADS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S041 |
Date Received | 05/28/2010 |
Decision Date | 07/30/2010 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS GERMANY GMBH, WIESBADEN, GERMANY AS AN ALTERNATE STERILIZATION FACILITY. |
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