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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 NameAPS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK
Classification Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
ApplicantPACESETTER, INC.
PMA NumberP880006
Supplement NumberS025
Date Received08/01/1996
Decision Date06/30/1997
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
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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