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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 NameMODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER
Classification Namegenerator, pulse, pacemaker, external programmable
Generic Namepacemaker
Regulation Number870.1750
ApplicantPACE MEDICAL
PMA NumberP920032
Supplement NumberS006
Date Received01/18/2001
Decision Date04/06/2001
Product Code
JOQ[ Registered Establishments with JOQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the temporary pacemakers by replacing the zener diodes used for protecting the internal electronics from high voltage transients with a transient voltage suppressor.
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