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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 NameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantBOSTON SCIENTIFIC CRV
PMA NumberP960040
Supplement NumberS271
Date Received09/11/2012
Decision Date10/05/2012
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 
Cleaning tool aid for the sealer heating plates.
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