|
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 | S352 |
Date Received | 12/18/2014 |
Decision Date | 02/25/2015 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODEL 3330 VERSION 20.0.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM (PCS) PROGRAMMER. |