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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.
 
Device\EART TRAK,HART TRAK III,MAX TRAK,MAX TRAK DP,PROA
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROOVE, MN 55311-1566
PMA NumberP840040
Supplement NumberS021
Date Received08/13/1990
Decision Date12/10/1990
Withdrawal Date 01/05/2007
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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