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.
Modified labeling for usci(r) probe iii(tm) balloon-on-a-wire(tm) dilatation system.
| 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 | 1996-12-20 |
| Decision Date | 1997-02-04 |
| PMA | P890048 |
| Supplement | S006 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| 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 |
| 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 |