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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.
 
DeviceLEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantLEOCOR, INC.
1301 REGENTS PK. DR.
HOUSTON, TX 77058
PMA NumberP890001
Supplement NumberS012
Date Received03/03/1995
Decision Date04/27/1995
Product Code LOX 
Advisory Committee Cardiovascular
Supplement Type 30-Day Supplement
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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