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 | TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE |
| Classification Name | Device. Laser Peripheral Angioplasty |
| Generic Name | Device. Laser Peripheral Angioplasty |
| Applicant | TRIMEDYNE, INC. |
| Date Received | 1989-11-24 |
| Decision Date | 1990-01-18 |
| PMA | P860042 |
| Supplement | S023 |
| Product Code | LWX |
| 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 |
|---|---|---|
| P860042 | Original Filing | |
| S027 | 1993-05-17 | Normal 180 Day Track |
| S026 | 1991-11-19 | Normal 180 Day Track |
| S025 | 1990-10-23 | Normal 180 Day Track |
| S024 | 1989-12-22 | Normal 180 Day Track |
| S023 | 1989-11-24 | Normal 180 Day Track |
| S022 | 1989-09-06 | Normal 180 Day Track |
| S021 | 1989-08-11 | Normal 180 Day Track |
| S020 | 1989-07-31 | Normal 180 Day Track |
| S019 | 1989-04-14 | Normal 180 Day Track |
| S018 | ||
| S017 | 1989-02-03 | Normal 180 Day Track |
| S016 | 1989-01-27 | Normal 180 Day Track |
| S015 | 1989-01-19 | Normal 180 Day Track |
| S014 | 1989-01-10 | Normal 180 Day Track |
| S013 | 1989-01-10 | Normal 180 Day Track |
| S012 | 1988-12-27 | Normal 180 Day Track |
| S011 | 1988-12-22 | Normal 180 Day Track |
| S010 | 1988-12-02 | Normal 180 Day Track |
| S009 | 1988-11-03 | Normal 180 Day Track |
| S008 | 1988-10-21 | Normal 180 Day Track |
| S007 | 1988-10-07 | Normal 180 Day Track |
| S006 | 1988-09-29 | Normal 180 Day Track |
| S005 | 1988-08-02 | Normal 180 Day Track |
| S004 | 1987-12-16 | Normal 180 Day Track |
| S003 | 1987-06-23 | Normal 180 Day Track |
| S002 | 1987-04-28 | Normal 180 Day Track |
| S001 | 1987-04-28 | Normal 180 Day Track |