|
Device | EPIC/EPIC+ AND ATLAS/ATLAS+ FAMILY OF PULSE GENERATORS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S101 |
Date Received | 02/15/2006 |
Decision Date | 03/14/2006 |
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 FROM A MANUAL TO AN AUTOMATED SYSTEM FOR THE SOLDERING OF THE OUTPUT FLEX TO FEEDTHRU SUBASSEMBLIES ON THE DEVICE. |