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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceUSCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantUsci, Div. C.R. Bard, Inc.
1200 Technology Park Dr.
P.O. Box 7025
Billerica, MA 01821
PMA NumberP890048
Supplement NumberS006
Date Received12/20/1996
Decision Date02/04/1997
Reclassified Date10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFIED LABELING FOR USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) DILATATION SYSTEM.
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