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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/ DISCOVERY/ MERIDIAN/ PULSAR
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP940031
Supplement NumberS059
Date Received11/01/2006
Decision Date02/08/2007
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE GUIDANT PULSE GENERATOR REPLACEMENT GUIDE WHICH PROVIDES IMPLANTING PHYSICIANS WITH GENERAL ADVICE ABOUT REMOVAL AND REPLACEMENT OF PULSE GENERATORS REACHING END OF LIFE.
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