|
Device | PARADYM RF CRT-D9750 |
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 | S065 |
Date Received | 04/24/2014 |
Decision Date | 06/27/2014 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MINOR DESIGN CHANGES TO THE SRAM AND ZENER DIODESFOR THE DEVICES. |
Post-Approval Study | Show Report Schedule and Study Progress |