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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 NumberS006
Date Received12/20/1996
Decision Date02/04/1997
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modified labeling for usci(r) probe iii(tm) balloon-on-a-wire(tm) dilatation system.
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