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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.
 
DeviceINTERTACH(R)II & RX2000(R) GRAPHICS PROGRAM MODULE
Generic NamePULSE-GENERATOR, SINGLE CHAMBER, SINGLE
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP860007
Supplement NumberS009
Date Received05/11/1992
Decision Date12/29/1992
Withdrawal Date07/19/2012
Product Code LWW 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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