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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.
 
DeviceMODEL 4553 DUAL CHAM. DDD TEMP.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 NumberS003
Date Received01/19/1996
Decision Date07/19/1996
Product Code JOQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ALTERNATE VENDOR FOR THE CALIBRATED MODULE ASSEMBLY FOR THE MICRO-PACE MODEL 4553, PART NUMBER 02-025-000
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