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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 RENEWAL TR
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Generic Namecardiac resynchronization therapy pacemaker (crt-p)
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP030005
Supplement NumberS067
Date Received08/05/2010
Decision Date04/08/2011
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a receiving inspection step for setscrews on header components.
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