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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 NameMICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER
Classification Namegenerator, pulse, pacemaker, external programmable
Generic Namepacemaker
Regulation Number870.1750
ApplicantPACE MEDICAL
PMA NumberP920032
Supplement NumberS002
Date Received11/27/1995
Decision Date04/26/1996
Product Code
JOQ[ Registered Establishments with JOQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the pacesetter, inc. , model 3070b private label version of the pace medical model 4575.
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