|
Device | PARADYM RF CRT-D9750 (ZL101) & (ZL102) ; INTENSIA CRT-D 174 |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P060027 |
Supplement Number | S077 |
Date Received | 07/02/2015 |
Decision Date | 07/31/2015 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement OPTIMIZE THE ELECTRICAL WELDING PROCESS FOR THE RF ANTENNA OF THE DEVICES. |