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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.
 
DeviceMODEL 2901 PROGRAMMERR SYSTEM
Generic NameProgrammer, pacemaker
Regulation Number870.3700
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP940031
Supplement NumberS005
Date Received03/25/1996
Decision Date11/07/1996
Product Code KRG 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR 1)A NEW PROGRAMMING SYSTEM, THE MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VIGOR FAMILY OF PULSE GENERATORS AND ACCESSORIES, AND 2) A NEW MANUFACTURING COTRACT FACILIYT, EMD ASSOCIATES, INC., (EMD), 4065 THEURER BLVD., WINONA, MN 55987
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