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 a change to the 5. 5f tec(r) cutter catheter, involving an increase in the skirt length of the cutter component from 0. 079 inches to 0. 104 inches.
| Device | IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) |
| Generic Name | Catheter, Coronary, Atherectomy |
| Applicant | INTENSIVE TECHNOLOGY, INC. |
| Date Received | 1997-10-28 |
| Decision Date | 1998-01-29 |
| PMA | P910019 |
| Supplement | S003 |
| Product Code | MCX |
| Docket Number | N |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |