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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 PROGRAMMER
Generic NameProgrammer, pacemaker
Regulation Number870.3700
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910077
Supplement NumberS014
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 A 1)NEW PROGRAMMING SYSTEM, THE MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VENTAK PRXII/PRXIII, MINI PULSE GENERTORS AND ACCESSORIES, AND 2) A NEW MANUFACTURING CONTRACT FACILITY, EMD ASSOCIATES, INC. (EMD), 4065 THEURER BLVD., WINONA, MN 55987
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