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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceLEOCOR,INC. MODELS 1
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantLEOCOR, INC.
1301 REGENTS PK. DR.
HOUSTON, TX 77058
PMA NumberP890001
Date Received02/09/1989
Decision Date03/30/1990
Product Code LOX 
Docket Number 90M-0142
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S004 S005 S006 S007 S009 S010 S011 S012 
S014 S015 S016 S018 S019 S020 
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