|
Device | EPIC HF/EPIC+ HF/EPIC II HF/EPIC II+HF/ATLAS HF/ATLAS+HF/ATLAS II HF/ATLAS II+HF CRT-DS/QUICKSITE/QUICKFLEX LEADS |
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 | S127 |
Date Received | 06/10/2009 |
Decision Date | 07/10/2009 |
Product Code |
NIK |
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 THREE STERILIZATION CHANGES. |