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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 NameGUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Name pulse generator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS064
Date Received08/12/2005
Decision Date09/07/2005
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 
Change in the method of attaching the header to the can involving roughening the area of attachment to improve bond strength.
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