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 | VISULAS ND:YAG LASER |
| 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 | CARL ZEISS, INC. |
| Date Received | 1986-11-14 |
| Decision Date | 1987-03-31 |
| Notice Date | 1987-05-13 |
| PMA | P850083 |
| Supplement | S004 |
| Product Code | LOI |
| Docket Number | 87M-0138 |
| 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 | CARL ZEISS, INC. one Zeiss Dr. thornwood, NY 10594 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850083 | Original Filing | |
| S008 | 1988-09-21 | Normal 180 Day Track |
| S007 | 1988-01-15 | Normal 180 Day Track |
| S006 | 1987-09-14 | Normal 180 Day Track |
| S005 | 1987-08-12 | Normal 180 Day Track |
| S004 | 1986-11-14 | Normal 180 Day Track |
| S003 | 1986-10-08 | Normal 180 Day Track |
| S002 | ||
| S001 | 1986-08-15 | Normal 180 Day Track |