|
Device | Platinum CARDIAC RESYNCHRONIZATION THERAPY DEFBRILLATOR CRT's |
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 | S084 |
Date Received | 08/09/2016 |
Decision Date | 09/07/2016 |
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 Platinium embedded software version 2.4.2. |