Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | AFP PACING SYSTEM |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P830045 |
Supplement Number | S053 |
Date Received | 08/01/1996 |
Decision Date | 06/30/1997 |
Withdrawal Date
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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 THE MODEL 3250 APSU PROGRAMMER WITH MODEL 3263 SOFTWARE AND MODEL 3251 BASE STATION WITH MODEL 3265 SOFTWARE. |
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