|
Device | EPIC HF/ATLAS + HF CRT-D |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030054 |
Supplement Number | S098 |
Date Received | 07/24/2008 |
Decision Date | 11/26/2008 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO ELIMINATE A CHEMICAL CLEANING PROCESS FOR TITANIUM CASE HALVES. |