|
Device | ELLIPSE/FORTIFY ASSURA FAMILY OS ICD'S |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S346 |
Date Received | 10/20/2014 |
Decision Date | 12/11/2014 |
Product Codes |
LWS OSR |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODEL EX2000 V8.0 SOFTWARE FOR THE MODELS EX1100AND EX1150 MERLIN@HOME TRANSMITTERS USED WITH THE DEVICES. |