|
Device | STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L 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 | S024 |
Date Received | 06/16/2011 |
Decision Date | 02/24/2012 |
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 ADDITION OF AN AUTOMATED PRODUCTION TEST PROCESS. |