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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameVENTAK(R) P2 SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namecardioverter
ApplicantBOSTON SCIENTIFIC
PMA NumberP930035
Date Received08/30/1993
Decision Date03/10/1995
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 95M-0072
Notice Date 04/21/1995
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 
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