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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 PRX AND VENTAK MINI SYSTEMS
Generic NamePacemaker/icd/crt non-implanted components
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910077
Supplement NumberS144
Date Received06/09/2014
Decision Date08/12/2014
Product Code OSR 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODEL 2909 MULTIPLE APPLICATION UTILITY SYSTEM SOFTWARE V9.03 AND MODEL 2905 PDF REPORT GENERATION SOFTWARE V1.02 WHICH RESIDE ON THE ZOOM LATITUDE PROGRAMMING SYSTEM MODEL 3120.
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