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 | ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 |
| 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 | NIDEK, INC. |
| Date Received | 1986-09-02 |
| Decision Date | 1986-12-01 |
| PMA | P830062 |
| Supplement | S010 |
| Product Code | LOI |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NIDEK, INC. 47651 Westinghouse Dr. fremont, CA 94539 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P830062 | Original Filing | |
| S016 | 1990-01-12 | Normal 180 Day Track |
| S015 | 1989-08-08 | Normal 180 Day Track |
| S014 | 1989-04-10 | Normal 180 Day Track |
| S013 | ||
| S012 | 1988-03-15 | Normal 180 Day Track |
| S011 | 1987-03-23 | Normal 180 Day Track |
| S010 | 1986-09-02 | Normal 180 Day Track |
| S009 | 1986-03-19 | |
| S008 | ||
| S007 | 1985-09-16 | |
| S006 | 1985-03-04 | |
| S005 | ||
| S004 | ||
| S003 | ||
| S002 | 1984-10-15 | |
| S001 | 1984-07-12 |