|
Device | Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) |
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 | S570 |
Date Received | 05/08/2023 |
Decision Date | 10/19/2023 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00180271
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement updated labeling to include information regarding the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) Post Approval Studies [ (PAS 1) PAS for the MADIT-CRT Indicated Patient Population, Utilizing Data from the NCDR ICD Registry; (PAS 2) Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy Post Approval Registry] |