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 | NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 |
| Classification Name | Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary |
| Generic Name | Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary |
| Applicant | COHERENT MEDICAL DIVISION |
| Date Received | 1988-05-18 |
| Decision Date | 1988-08-30 |
| PMA | P830054 |
| Supplement | S021 |
| Product Code | LOI |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COHERENT MEDICAL DIVISION 3270 West Bayshore Rd. p.o. Box 10122 palo Alto, CA 94303 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P830054 | Original Filing | |
| S022 | 1989-08-03 | Normal 180 Day Track |
| S021 | 1988-05-18 | Normal 180 Day Track |
| S020 | 1987-07-08 | Normal 180 Day Track |
| S019 | 1987-04-30 | Normal 180 Day Track |
| S018 | 1987-04-01 | Normal 180 Day Track |
| S017 | 1987-03-09 | Normal 180 Day Track |
| S016 | 1986-10-10 | Normal 180 Day Track |
| S015 | 1986-09-09 | Normal 180 Day Track |
| S014 | ||
| S013 | 1986-09-08 | Normal 180 Day Track |
| S012 | 1986-09-08 | Normal 180 Day Track |
| S011 | 1986-07-08 | Normal 180 Day Track |
| S010 | 1986-07-08 | Normal 180 Day Track |
| S009 | 1986-05-28 | Normal 180 Day Track |
| S008 | ||
| S007 | ||
| S006 | 1985-06-21 | |
| S005 | 1985-01-03 | |
| S004 | ||
| S003 | 1984-12-10 | Normal 180 Day Track |
| S002 | 1984-11-27 | |
| S001 | 1984-11-20 |