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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-ST
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantLeocor, Inc.
1301 Regents Pk. Dr.
Houston, TX 77058
PMA NumberP890001
Supplement NumberS019
Date Received10/03/1996
Decision Date06/09/1997
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 A MODIFIED VERSION OF THE PICO-ST(TM) PTCA CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PICO-ST(TM) II PTCA CATHETER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
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