|
Device | COROX OTW 75-UP STEROID,COROX OTW 85 UP STEROID |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P050023 |
Supplement Number | S084 |
Date Received | 03/06/2015 |
Decision Date | 07/17/2015 |
Product Code |
MRM |
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. |