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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 P 1600 AICD AND 2830 SOFTWARE MODULE
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepacemaker
ApplicantBOSTON SCIENTIFIC
PMA NumberP890061
Date Received11/27/1989
Decision Date05/02/1991
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 91M-0184
Notice Date 06/13/1991
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S005 S006 S008 
S009 S010 S011 S012 S013 S014 
S015 S016 S017 S018 S019 S020 
S021 S022 
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