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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 PERCUTANEOUS ANGIOPLASTY CATHETER (PTCA), MODEL 5S, LEOCOR CORFLO MODEL 7.5PT COATED PTCA, AND CORFLO HEMO PUMP
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantLEOCOR, INC.
1301 REGENTS PK. DR.
HOUSTON, TX 77058
PMA NumberP890001
Supplement NumberS011
Date Received09/01/1994
Decision Date06/13/1996
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES IN THE INSTRUCTIONS FOR USE, THE ADDITION OF A PUMP HEAD WITH LONGER TUBING, A CHANGE IN THE CLEANING PROCESS, AND THE ADDITION OF STOPCOCKS ON THE PUMPS
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