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 | 8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER |
Classification Name | Device, Angioplasty, Laser, Coronary |
Generic Name | Device, Angioplasty, Laser, Coronary |
Applicant | TRIMEDYNE, INC. |
Date Received | 1989-09-28 |
Decision Date | 1990-04-04 |
PMA | P870043 |
Supplement | S008 |
Product Code | LPC |
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 |
---|---|---|
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 |