|
Device | Promote+ / Unify Quadra /Unity 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 | S335 |
Date Received | 08/01/2017 |
Decision Date | 08/23/2017 |
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 Changes to the foil etching manufacturing process for high voltage capacitors. |