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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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval is for an alternate vendor located at Princeton Technology, Inc., 12 Park Avenue, Hudson, New Hampshire.
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