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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.
 
DeviceMICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER
Classification Namegenerator, pulse, pacemaker, external programmable
Generic Namegenerator, pulse, pacemaker, external programmable
Regulation Number870.1750
Applicant
PACE MEDICAL
391 totten pond rd.
waltham, MA 02451
PMA NumberP920032
Supplement NumberS005
Date Received06/25/1999
Decision Date02/02/2000
Product Code
JOQ[ Registered Establishments with JOQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval is for an alternate vendor located at princeton technology, inc. , 12 park avenue, hudson, new hampshire.
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