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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePOLARITY PULSE GENERATOR MODELS 209K AND 2091M/S
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacemaker programmer and base station
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP880086
Supplement NumberS049
Date Received06/30/1998
Decision Date07/14/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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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