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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.
 
DeviceVIGOR MODEL 2880 SOFTWARE APPLICATION (REV 3.0)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP940031
Supplement NumberS008
Date Received01/17/1997
Decision Date03/25/1997
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 VIGOR MODEL 2880 SOFTWARE APPLICATION VERSION 3.0, TO BE USED WITH MODEL 2950 OR MODEL 2901 PROGRAMMER/RECORDER/MONITOR DEVICES.
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