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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 DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER
Generic NameGenerator, pulse, pacemaker, external programmable (for electrophysiological studies only)
ApplicantPACE MEDICAL
391 TOTTEN POND RD.
WALTHAM, MA 02451
PMA NumberP920032
Supplement NumberS005
Date Received06/25/1999
Decision Date02/02/2000
Product Codes DTE JOQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval is for an alternate vendor located at Princeton Technology, Inc., 12 Park Avenue, Hudson, New Hampshire.
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