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.
Requested the device which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing biological indicators.
| Device | PERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1998-06-25 |
| Decision Date | 1998-07-09 |
| PMA | P790020 |
| Supplement | S058 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADVANCED MEDICAL OPTICS, INC. 1700 East St. Andrew Pl. santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P790020 | Original Filing | |
| S059 | 1998-10-13 | Real-time Process |
| S058 | 1998-06-25 | 30-day Notice |
| S057 | ||
| S056 | 1995-03-27 | Normal 180 Day Track |
| S055 | ||
| S054 | 1993-11-09 | Normal 180 Day Track |
| S053 | 1991-04-17 | Normal 180 Day Track |
| S052 | ||
| S051 | 1989-07-21 | Normal 180 Day Track |
| S050 | 1989-07-19 | Normal 180 Day Track |
| S049 | 1989-06-19 | Normal 180 Day Track |
| S048 | ||
| S047 | 1989-05-16 | Normal 180 Day Track |
| S046 | 1989-04-12 | Normal 180 Day Track |
| S045 | ||
| S044 | 1988-11-09 | Normal 180 Day Track |
| S043 | 1988-11-09 | Normal 180 Day Track |
| S042 | 1988-05-26 | Panel Track |
| S041 | 1988-05-19 | Normal 180 Day Track |
| S040 | 1988-04-27 | Special (immediate Track) |
| S039 | 1988-03-29 | Normal 180 Day Track |
| S038 | 1988-03-14 | Normal 180 Day Track |
| S037 | 1987-07-02 | Normal 180 Day Track |
| S036 | 1987-02-17 | 30-Day Supplement |
| S035 | 1987-01-20 | Normal 180 Day Track |
| S034 | 1986-04-02 | |
| S033 | 1985-11-25 | |
| S032 | 1985-09-06 | |
| S031 | 1985-03-25 | |
| S030 | 1984-10-01 | |
| S029 | 1984-07-02 | |
| S028 | 1984-06-26 | |
| S027 | 1984-05-30 | |
| S026 | ||
| S025 | 1984-05-17 | |
| S024 | 1984-05-15 | |
| S023 | 1984-02-06 | |
| S022 | 1984-01-11 | |
| S021 | 1984-01-10 | |
| S020 | ||
| S019 | 1983-11-30 | |
| S018 | 1983-11-23 | |
| S017 | 1983-10-06 | |
| S016 | ||
| S015 | 1983-09-09 | |
| S014 | ||
| S013 | 1983-07-01 | |
| S012 | 1983-06-08 | |
| S011 | 1983-06-08 | |
| S010 | 1982-06-15 | |
| S009 | 1982-09-29 | |
| S008 | 1982-08-26 | |
| S007 | ||
| S006 | 1982-05-18 | |
| S005 | 1982-05-03 | |
| S004 | 1981-12-04 | |
| S003 | 1981-09-21 | |
| S002 | 1981-09-01 | |
| S001 | 1980-05-02 |