PMA P890048S006
- Device
- USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS
- Applicant
- Usci, Div. C.R. Bard, Inc.
- PMA number
- P890048
- Supplement
- S006
- Product code
- LOX
- Decision date
- 1997-02-04
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- MODIFIED LABELING FOR USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) DILATATION SYSTEM.
Current openFDA PMA Record#
- Device
- USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS
- Applicant
- Usci, Div. C.R. Bard, Inc.
- PMA number
- P890048
- Supplement
- S006
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-02-04
- Decision code
- APPR
- Date received
- 1996-12-20
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- MODIFIED LABELING FOR USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) DILATATION SYSTEM.