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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 DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER
Classification Namegenerator, pulse, pacemaker, external programmable
Generic Namepacemaker
Regulation Number870.1750
ApplicantPACE MEDICAL
PMA NumberP920032
Supplement NumberS005
Date Received06/25/1999
Decision Date02/02/2000
Product Code
JOQ[ Registered Establishments with JOQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval is for an alternate vendor located at princeton technology, inc. , 12 park avenue, hudson, new hampshire.
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