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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER
Generic NameGenerator, pulse, pacemaker, external programmable (for electrophysiological studies only)
Regulation Number870.1750
ApplicantPACE MEDICAL
391 TOTTEN POND RD.
WALTHAM, MA 02451
PMA NumberP920032
Supplement NumberS002
Date Received11/27/1995
Decision Date04/26/1996
Product Code JOQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE PACESETTER, INC., MODEL 3070B PRIVATE LABEL VERSION OF THE PACE MEDICAL MODEL 4575
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