|
Device | CURRENT, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILIES OF ICD DEVICE |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S340 |
Date Received | 06/16/2014 |
Decision Date | 07/10/2014 |
Product Code |
LWS |
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 CHANGE IN THE TEMPERATURE CYCLING RANGE FOR HYBRID ASSEMBLIES. |