|
Device | Quickflex u, Quartet Cardiac Resynchronization Therapy Passive |
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 | S367 |
Date Received | 11/30/2018 |
Decision Date | 12/17/2018 |
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 Acquire curing trays and Teflon coating services from alternate suppliers for use in the curing process when creating Optim E2A resin pellets. |