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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 III MODEL 3500 PROGRAMMER
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS041
Date Received07/31/1997
Decision Date10/07/1997
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the APS III Model 3500 Programmer with Model 3302 Software.
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