|
Device | APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P880006 |
Supplement Number | S025 |
Date Received | 08/01/1996 |
Decision Date | 06/30/1997 |
Withdrawal Date
|
05/07/2018 |
Product Code |
DXY |
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 THE MODEL 3250 APSU PROGRAMMER WITH MODEL 3263 SOFTWARE AND MODEL 3251 BASE STATION WITH MODEL 3265 SOFTWARE. |