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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 PICO RUNNER(TM) PTCA CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantLeocor, Inc.
1301 Regents Pk. Dr.
Houston, TX 77058
PMA NumberP890001
Supplement NumberS015
Date Received12/01/1995
Decision Date06/07/1996
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN EXTENSION OF THE LEOCOR PICO RUNNER PTCA CATHETER LINE TO INCLUDE A 4.0MM BALLOON DIAMETER
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