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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameLEOCOR,INC. MODELS 1
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheters
Regulation Number870.5100
ApplicantLEOCOR, INC.
PMA NumberP890001
Date Received02/09/1989
Decision Date03/30/1990
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 90M-0142
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
S011 S012 S014 S015 S016 S018 S019 S020 
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