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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 NameUSCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namedilatation system
Regulation Number870.5100
ApplicantUSCI, DIV. C.R. BARD, INC.
PMA NumberP890048
Supplement NumberS004
Date Received04/10/1995
Decision Date06/14/1995
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
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