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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 NumberS026
Date Received02/02/1998
Decision Date05/07/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the regency sc+, regency sc, and regency scx pulse generators which are programmed by the aps ii programmer with model 3204a function pack.
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