|
Device | EPIC II/II + DR/VR & ATLAS II/II + DR/VR ICDS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S116 |
Date Received | 08/28/2006 |
Decision Date | 09/21/2006 |
Product Code |
NVZ |
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 DELTA BATTERY VOLTAGE TEST TO A DIRECT IBAT CURRENT MEASUREMENT METHOD AND THE ELIMINATION OF A 14-DAY HOLD PERIOD DURING MANUFACTURING. |