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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 Namegenerator, pulse, pacemaker, external programmable
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 - indications/instructions/shelf life/tradename
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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