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 | BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS |
| Generic Name | Lens, Contact (polymethylmethacrylate) |
| Applicant | POLYMER TECHNOLOGY CORP. |
| Date Received | 1990-03-16 |
| Decision Date | 1990-03-29 |
| PMA | P820065 |
| Supplement | S068 |
| Product Code | HPX |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-Day Supplement |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | POLYMER TECHNOLOGY CORP. 100 Research Dr. wilmington, MA 01887 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820065 | Original Filing | |
| S082 | 1994-01-14 | Normal 180 Day Track |
| S081 | 1993-08-02 | Normal 180 Day Track |
| S080 | 1993-08-02 | Normal 180 Day Track |
| S079 | 1992-06-30 | Normal 180 Day Track |
| S078 | 1992-03-03 | Normal 180 Day Track |
| S077 | 1992-01-16 | Normal 180 Day Track |
| S076 | 1992-01-03 | Normal 180 Day Track |
| S075 | 1991-03-20 | Normal 180 Day Track |
| S074 | 1991-03-04 | Normal 180 Day Track |
| S073 | 1990-12-31 | 30-Day Supplement |
| S072 | 1990-11-06 | Normal 180 Day Track |
| S071 | 1990-10-01 | Normal 180 Day Track |
| S070 | 1990-05-11 | Normal 180 Day Track |
| S069 | ||
| S068 | 1990-03-16 | 30-Day Supplement |
| S067 | 1990-03-12 | 30-Day Supplement |
| S066 | 1990-02-07 | Normal 180 Day Track |
| S065 | 1989-11-30 | Normal 180 Day Track |
| S064 | 1989-11-13 | Normal 180 Day Track |
| S063 | 1989-07-27 | Normal 180 Day Track |
| S062 | 1989-07-18 | Normal 180 Day Track |
| S061 | 1989-06-23 | Normal 180 Day Track |
| S060 | 1988-12-02 | Normal 180 Day Track |
| S059 | 1988-10-27 | 30-Day Supplement |
| S058 | 1988-08-03 | 30-Day Supplement |
| S057 | 1988-07-19 | 30-Day Supplement |
| S056 | 1988-06-13 | 30-Day Supplement |
| S055 | ||
| S054 | 1988-05-12 | Normal 180 Day Track |
| S053 | 1988-02-09 | Special (immediate Track) |
| S052 | 1988-02-03 | Normal 180 Day Track |
| S051 | 1988-01-15 | 30-Day Supplement |
| S050 | ||
| S049 | 1987-09-18 | Normal 180 Day Track |
| S048 | 1987-08-07 | 30-Day Supplement |
| S047 | 1987-08-04 | 30-Day Supplement |
| S046 | ||
| S045 | 1987-07-21 | Normal 180 Day Track |
| S044 | 1987-07-14 | 30-Day Supplement |
| S043 | 1987-05-06 | 30-Day Supplement |
| S042 | 1987-02-25 | 30-Day Supplement |
| S041 | ||
| S040 | ||
| S039 | 1986-11-04 | 30-Day Supplement |
| S038 | 1986-10-28 | 30-Day Supplement |
| S037 | ||
| S036 | 1986-08-12 | Normal 180 Day Track |
| S035 | 1986-06-24 | 30-Day Supplement |
| S034 | 1986-06-13 | Normal 180 Day Track |
| S033 | 1986-05-20 | |
| S032 | 1986-03-18 | |
| S031 | ||
| S030 | 1986-01-29 | |
| S029 | ||
| S028 | 1985-12-19 | |
| S027 | 1985-10-25 | |
| S026 | 1985-10-10 | |
| S025 | 1985-09-09 | |
| S024 | ||
| S023 | 1985-08-07 | |
| S022 | 1985-06-21 | |
| S021 | 1985-05-07 | |
| S020 | 1985-04-09 | |
| S019 | 1985-03-27 | |
| S018 | 1985-02-15 | |
| S017 | 1985-02-04 | |
| S016 | 1985-02-04 | |
| S015 | 1984-12-17 | |
| S014 | 1984-10-09 | |
| S013 | 1984-10-05 | |
| S012 | 1984-08-20 | |
| S011 | 1984-07-02 | |
| S010 | 1984-06-14 | |
| S009 | 1984-05-11 | |
| S008 | 1984-05-22 | |
| S007 | 1984-05-22 | |
| S006 | 1984-04-30 | |
| S005 | 1984-03-12 | |
| S004 | ||
| S003 | ||
| S002 | ||
| S001 | 1983-09-15 |