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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 NameCOGNIS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
ApplicantBOSTON SCIENTIFIC CORPORATION (BSC)
PMA NumberP010012
Supplement NumberS226
Date Received11/25/2009
Decision Date12/22/2009
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 
Addition of two new acceptance activities to the final inspection at the supplier.
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