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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceAPS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantSt. Jude Medical, Inc.
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP880006
Supplement NumberS025
Date Received08/01/1996
Decision Date06/30/1997
Withdrawal Date05/07/2018
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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