USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS
FDA premarket approval P890048/S006 · decided 1997-02-04
Approval details
- PMA number
- P890048
- Supplement
- S006
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- 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
- 1996-12-20
- Decision date
- 1997-02-04
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Billerica, MA
- Statement
- MODIFIED LABELING FOR USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) DILATATION SYSTEM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| USCI INPUT INTRODUCER SET (K940092) | Usci, Div. C.R. Bard, Inc. | 1995-08-10 |
| USCI DORROS INFUSION/PROBING CATHETER (K884209) | Usci, Div. C.R. Bard, Inc. | 1988-12-21 |
| CATHETER, CARDIOVASCULAR (K771823) | Usci, Div. C.R. Bard, Inc. | 1977-12-20 |
| 888 ARTERIAL/VENOUS CATHETER INTRODUCER (K771982) | Usci, Div. C.R. Bard, Inc. | 1977-11-02 |
| TRC STAINLESS STEEL SAFETY SPRING GUIDES (K772021) | Usci, Div. C.R. Bard, Inc. | 1977-11-02 |
| PATCH FABRIC (K770835) | Usci, Div. C.R. Bard, Inc. | 1977-10-05 |
| CATHETER,PERCUTANEOUS INTRODUC. & SHEATH (K770561) | Usci, Div. C.R. Bard, Inc. | 1977-04-26 |
| SAUVAGE FILAMENTOUS PROSTHESES (K770236) | Usci, Div. C.R. Bard, Inc. | 1977-02-25 |