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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 NameVENTAK AV, VENTAK PRIZM DR/VR, VITALITY, CONFIENT, AND TELIGEN, PUNCTUA, ENERGEN, AND INCEPTA ICD FAMILIES
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP960040
Supplement NumberS281
Date Received11/08/2012
Decision Date12/05/2012
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 
Replace the traceability and tracking system.
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