Premarket Approval (PMA)

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.

• Device: USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS
• Generic Name: Catheters, transluminal coronary angioplasty, percutaneous
• Regulation Number: 870.5100
• Applicant: Usci, Div. C.R. Bard, Inc.; 1200 Technology Park Dr.; P.O. Box 7025; Billerica, MA 01821
• PMA Number: P890048
• Supplement Number: S003
• Date Received: 07/15/1992
• Decision Date: 05/17/1995
• Reclassified Date: 10/08/2010
• Product Code: LOX
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No