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.
| Device | SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER |
| Classification Name | Device, Angioplasty, Laser, Coronary |
| Generic Name | Device, Angioplasty, Laser, Coronary |
| Applicant | TRIMEDYNE, INC. |
| Date Received | 1991-04-23 |
| Decision Date | 1992-01-29 |
| PMA | P870043 |
| Supplement | S014 |
| Product Code | LPC |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TRIMEDYNE, INC. 25901 Commercentre Dr lake Forest, CA 92630 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870043 | Original Filing | |
| S016 | 1991-11-19 | Normal 180 Day Track |
| S015 | 1991-08-29 | Normal 180 Day Track |
| S014 | 1991-04-23 | Normal 180 Day Track |
| S013 | 1990-12-06 | Normal 180 Day Track |
| S012 | ||
| S011 | 1990-04-30 | Normal 180 Day Track |
| S010 | 1989-12-22 | Normal 180 Day Track |
| S009 | 1989-10-26 | Normal 180 Day Track |
| S008 | 1989-09-28 | Normal 180 Day Track |
| S007 | 1989-02-03 | Normal 180 Day Track |
| S006 | 1989-01-10 | Normal 180 Day Track |
| S005 | 1988-12-27 | Normal 180 Day Track |
| S004 | 1988-11-23 | Normal 180 Day Track |
| S003 | 1988-11-03 | Normal 180 Day Track |
| S002 | 1988-10-13 | Normal 180 Day Track |
| S001 | 1988-09-14 | Normal 180 Day Track |