This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | USCI, DIV. C.R. BARD, INC. |
| Date Received | 1989-08-29 |
| Decision Date | 1991-04-17 |
| Notice Date | 1991-06-06 |
| PMA | P890048 |
| Supplement | S |
| Product Code | LOX |
| Docket Number | 91M-0157 |
| Advisory Committee | Cardiovascular |
| 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 |