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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 ANGIOPLASTY CATHETER (PTCA), MODEL 5S, LEOCOR CORFLO MODEL 7.5PT COATED PTCA, AND CORFLO HEMO PUMP
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheters
Regulation Number870.5100
ApplicantLEOCOR, INC.
PMA NumberP890001
Supplement NumberS011
Date Received09/01/1994
Decision Date06/13/1996
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 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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