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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameUSCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameballoon dilatation system with 2.5 cm tip
Regulation Number870.5100
ApplicantUSCI, DIV. C.R. BARD, INC.
PMA NumberP890048
Date Received08/29/1989
Decision Date04/17/1991
Reclassified Date 10/08/2010
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 91M-0157
Notice Date 06/06/1991
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S003 S004 S005 S006 
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