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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 NameTEMPO DR 2102 AND TEMP D 2902
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacing system
Regulation Number870.3610
ApplicantPACESETTER, INC.
PMA NumberP900070
Supplement NumberS014
Date Received09/16/1996
Decision Date08/27/1997
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 tempo dr model 2102, tempo d model 2902, tempo vr model 1102, and tempo v model 1902 pulse generators.
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