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.
Approval to change vendors of the polymethylmethacrylate (pmma) material used to manufacture iols aproved under this pma and its supplements
| Device | SINGLE-PIECE AND THREE PIECE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | ADVANCED VISION SCIENCE |
| Date Received | 1994-07-28 |
| Decision Date | 1996-01-29 |
| PMA | P830033 |
| Supplement | S027 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADVANCED VISION SCIENCE 5743 Thornwood Dr. goleta, CA 93117 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P830033 | Original Filing | |
| S027 | 1994-07-28 | Normal 180 Day Track |
| S026 | 1994-01-31 | Normal 180 Day Track |
| S025 | ||
| S024 | 1991-04-04 | Normal 180 Day Track |
| S023 | 1990-10-10 | Normal 180 Day Track |
| S022 | ||
| S021 | 1990-04-06 | Normal 180 Day Track |
| S020 | ||
| S019 | ||
| S018 | 1989-12-27 | Normal 180 Day Track |
| S017 | ||
| S016 | 1988-11-14 | Normal 180 Day Track |
| S015 | 1988-11-09 | Panel Track |
| S014 | 1988-09-29 | Panel Track |
| S013 | 1988-07-12 | Normal 180 Day Track |
| S012 | 1988-06-06 | Normal 180 Day Track |
| S011 | ||
| S010 | 1986-11-13 | Normal 180 Day Track |
| S009 | 1986-11-10 | Normal 180 Day Track |
| S008 | 1986-11-04 | Normal 180 Day Track |
| S007 | 1986-08-29 | Normal 180 Day Track |
| S006 | 1986-06-09 | Normal 180 Day Track |
| S005 | 1986-03-28 | |
| S004 | 1986-04-14 | |
| S003 | 1986-04-14 | |
| S002 | 1985-10-16 | |
| S001 | 1983-07-25 |