|
Device | AUTIMA/AURORA CARDIAC PACING SYSTEM |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P820018 |
Supplement Number | S061 |
Date Received | 11/08/1993 |
Decision Date | 07/12/1995 |
Withdrawal Date
|
06/20/2007 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDITION OF NON-INVASIVE PROGRAMMED STIMULATION (NIPS) |