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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER).
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal coronary angioplasty (ptca) balloon catheter
Regulation Number870.5100
ApplicantENDOLOGIX, INC.
PMA NumberP970052
Supplement NumberS001
Date Received03/03/1997
Decision Date04/08/1998
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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