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.
Approval for modifications to the rear seal assembly of the tec drive component of the tec coronary atherectomy system
| Device | IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) |
| Generic Name | Catheter, Coronary, Atherectomy |
| Applicant | INTENSIVE TECHNOLOGY, INC. |
| Date Received | 1996-08-27 |
| Decision Date | 1996-09-17 |
| PMA | P910019 |
| Supplement | S002 |
| Product Code | MCX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Other Report |
| 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 |