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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLEOCOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED)
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheters
Regulation Number870.5100
ApplicantLEOCOR, INC.
PMA NumberP890001
Supplement NumberS014
Date Received06/21/1995
Decision Date06/13/1996
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type 30-Day Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised labeling.
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