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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 AV III DR PULSE GENERATOR AND VENTAK AV DR SOFTWARE APPLICATION
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960040
Supplement NumberS006
Date Received04/22/1998
Decision Date08/31/1998
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the VENTAK(R) AV III DR AICD(TM) System with Model 2843 Software, Version 2.6, the use of Version 2.6 with the VENTAK(R) AV II DR System and modifications to the Physician's Manual and the DR System and modifications tot he Physicians's Manual and the Patient's Manual.
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