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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.
 
DeviceCORONARY BALLOON DILITATION CATHETERS PTCA
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROOVE, MN 55311-1566
PMA NumberP840040
Supplement NumberS042
Date Received12/23/1993
Decision Date01/23/1995
Withdrawal Date 01/05/2007
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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