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 | COROX OTW 75-BP, COROX OTW 85-BP,COROX OTW-S 75-BP,COROX OTW-S 85-BP,COROX OTW-L 75-BP,COROX OTW-L 85-BP |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P070008 |
Supplement Number | S061 |
Date Received | 03/06/2015 |
Decision Date | 07/17/2015 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR IMPLEMENTATION OF PARAMETRIC RELEASE IN PLACE OF CONVENTIONAL PRODUCT RELEASE IN THE STERILIZATION PROCESS FOR PERMANENT PACEMAKER AND DEFIBRILLATION LEADS. |
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