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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.
 
DeviceMODEL 4553 DUAL CHAM. DDD TEMP.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 NumberS004
Date Received01/30/1998
Decision Date02/27/1998
Product Code
JOQ[ Registered Establishments with JOQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified switch guard design.
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