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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.
 
DevicePOLARITY PULSE GENERATOR MODELS 209K AND 2091M/S
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS048
Date Received06/12/1998
Decision Date07/14/1998
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for software modifications to the APS III Programmer Software Model 3302 Revision B (Paragon Version 1.02) resulting in APS III Programmer Software Model 3302 revision C (Paragon Version 1.03).
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