|
Device | PARADYM VR 8750, PARADYM DR 8750, PARADYM RF CRT-D |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S093 |
Date Received | 02/12/2014 |
Decision Date | 04/09/2014 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MINOR DESIGN CHANGES TO THE SRAM AND ZENER DIODESFOR THE DEVICES. |