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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 CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheters
Regulation Number870.5100
ApplicantLEOCOR, INC.
PMA NumberP890001
Supplement NumberS016
Date Received04/18/1996
Decision Date09/17/1996
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the leocor 30 mm pico runner percutaneous transluminal coronary angioplasty (ptca) catheter.
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