USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

FDA Premarket Approval P890048 S004

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.

Pre-market Approval Supplement Details

• Device: USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS
• Generic Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous
• Applicant: USCI, DIV. C.R. BARD, INC.
• Date Received: 1995-04-10
• Decision Date: 1995-06-14
• PMA: P890048
• Supplement: S004
• Product Code: LOX
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Supplement
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: USCI, DIV. C.R. BARD, INC. 1200 Technology Park Dr. p.o. Box 7025 billerica, MA 01821

Supplemental Filings

Supplement Number	Date	Supplement Type
P890048		Original Filing
S006	1996-12-20	Special (immediate Track)
S005	1996-09-05	Normal 180 Day Track
S004	1995-04-10	30-Day Supplement
S003	1992-07-15	Normal 180 Day Track
S002
S001