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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 2DR/VR AICD SYSTEMS & MODEL 2844, VERSION 3.1 SOFTWARE
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N.
Alternate Contact, MN 55112
PMA NumberP960040
Supplement NumberS015
Date Received06/08/2000
Decision Date08/04/2000
Product Codes KRG LWP 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE PULSE GENERATOR MODELS 1860 AND 1861, PULSE GENERATOR SOFTWARE VERSION 1.3, AND PROGRAM/RECORDER/MONITOR SOFTWARE MODEL 2844, VERSION 3.1.
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