|
Device | Cardiac Resynchronization Therapy (CRT) |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030054 |
Supplement Number | S387 |
Date Received | 10/21/2020 |
Decision Date | 11/20/2020 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Process improvements and changes associated with the optimized drug release/elution test method for batch release and annual stability for CRT leads MCRD component manufacturing. |