|
Device | CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) |
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 | S173 |
Date Received | 10/29/2010 |
Decision Date | 11/29/2011 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR PROMOTE Q MODEL CD3221-36 CRT-D, PROMOTE QUADRA MODELS CD 3245-40/40Q CRT-D, UNIFY QUADRA CRT-D MODELS CD3249-40/40Q CRT-D, QUARTET MODEL 1458Q LV LEAD, AND MODEL 3330 VERSION 12.1.1 PROGRAMMER SOFTWARE. |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |