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 | 1988-12-02 |
Decision Date | 1989-05-01 |
PMA | P860042 |
Supplement | S010 |
Product Code | LWX |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
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 |