|
Device | FORTIFY, FORTIFY ASSURA AND ELLIPSE ICDS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S329 |
Date Received | 02/05/2014 |
Decision Date | 03/04/2014 |
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 IMPLEMENT CHANGES TO THE PARYLENE REMOVAL PROCESS USED DURING ICD AND CRT-D MANUFACTURE. |