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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.
 
Trade NameCONTAK CD, CONTAK RENEWAL, EASYTRAK
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Name pulse generator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS052
Date Received06/27/2005
Decision Date07/08/2005
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes in procedures for cytotoxicity and pyrogenicity testing for inspections of incoming components.
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