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 | CLASSIC SERIES TM POSTERIOR CHAMBER INTRAOCULAR |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | NEWLENSCO |
| Date Received | 1988-08-10 |
| Decision Date | 1989-12-06 |
| PMA | P870075 |
| Supplement | S001 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NEWLENSCO 1911 Walker Ave. monrovia, CA 91016 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870075 | Original Filing | |
| S004 | 1991-09-24 | Normal 180 Day Track |
| S003 | 1991-01-24 | Normal 180 Day Track |
| S002 | ||
| S001 | 1988-08-10 | Panel Track |