|
Device | ELLIPSE / FORTIFY ASSURA FAMILY OF ICD'S |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S342 |
Date Received | 07/02/2014 |
Decision Date | 09/12/2014 |
Product Code |
LWS |
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 THE MERLIN PATIENT CARE SYSTEM PROGRAMMER SOFTWARE MODEL 3330 VERSION 19.1. |
Approval Order | Approval Order |