|
Device | CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S526 |
Date Received | 10/16/2020 |
Decision Date | 11/12/2020 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT03237858
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to suspend enrollment in the MANAGE-HF Phase II Post-Approval Study for six (6) months due to COVID-19. |