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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.
 
DevicePRIZM AND VITALITY FAMILY
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960040
Supplement NumberS238
Date Received09/24/2010
Decision Date11/19/2010
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE SOFTWARE FOR THE LATITUDE INDUCTIVE COMMUNICATOR (MODEL 6481).
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