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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.
 
DeviceLYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER).
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantEndologix, Inc.
11 Studebaker
Irvine, CA 92618
PMA NumberP970052
Supplement NumberS001
Date Received03/03/1997
Decision Date04/08/1998
Withdrawal Date03/30/2009
Product Code LOX 
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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