|
Device | PARADYM CRT-D 8750, PARADYM RF CRT-D 9750 |
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 | S061 |
Date Received | 03/18/2014 |
Decision Date | 04/17/2014 |
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 |
Approval Order Statement APPROVAL FOR DESIGN CHANGES TO THE SETSCREWS AND TORQUE SCREWDRIVER USED IN CONNECTING THE LEADS TO IMPLANTABLE DEFIBRILLATORS. |