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 | IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) |
| Generic Name | Catheter, Coronary, Atherectomy |
| Applicant | INTENSIVE TECHNOLOGY, INC. |
| Date Received | 1991-03-29 |
| Decision Date | 1993-05-18 |
| Notice Date | 1993-07-27 |
| PMA | P910019 |
| Supplement | S |
| Product Code | MCX |
| Docket Number | 93M-0209 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INTENSIVE TECHNOLOGY, INC. 3574 Ruffin Rd. san Diego, CA 92123 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910019 | Original Filing | |
| S005 | 1998-01-29 | Normal 180 Day Track |
| S004 | 1997-10-30 | Normal 180 Day Track |
| S003 | 1997-10-28 | Special (immediate Track) |
| S002 | 1996-08-27 | Special (immediate Track) |
| S001 | 1994-06-13 | Normal 180 Day Track |