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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 NameSOFTWARE MODEL 3264 REV A
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable cardiac pacemaker pulse generator
Regulation Number870.3610
ApplicantPACESETTER, INC.
PMA NumberP880006
Supplement NumberS030
Date Received09/07/1999
Decision Date09/24/1999
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 the model 3264 rev a programmer software for use with the model 3250 apsu programmer.
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