|
Device | Unify/ Unify Quadra/ Unify Assura/ Quadra Assura/ Quadra Assura MP |
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 | S342 |
Date Received | 11/13/2017 |
Decision Date | 12/11/2017 |
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 Alternate high voltage capacitor stack process with automated inspection and placement. |