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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVENTAK PRIZM DR/VR AICD
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N.
Alternate Contact, MN 55112
PMA NumberP960040
Supplement NumberS012
Date Received08/23/1999
Decision Date01/21/2000
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval is for modifications to VENTAK DR/VR AICD. The device, as modified, will be marketed under the tradename VENTAK PRIZM DR/VR AICD System, Models 1850, 1851, 1855 and 1856 with Model 2844 Software, Version 1.1 and the indications remains the same as in the original PMA.
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