This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS |
| Classification Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
| Generic Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
| Applicant | POLYMER TECHNOLOGY CORP. |
| Date Received | 1986-06-02 |
| Decision Date | 1987-11-30 |
| Notice Date | 1988-01-19 |
| PMA | P860022 |
| Supplement | S |
| Product Code | MWL |
| Docket Number | 87M-0395 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | POLYMER TECHNOLOGY CORP. 1400 N. Goodman St. rochester, NY 14692 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860022 | Original Filing | |
| S059 | 2016-06-27 | 30-day Notice |
| S058 | 2011-05-31 | 30-day Notice |
| S057 | 2008-01-31 | Real-time Process |
| S056 | 2006-01-27 | 135 Review Track For 30-day Notice |
| S055 | 2003-10-28 | Real-time Process |
| S054 | 2002-01-30 | Normal 180 Day Track |
| S053 | 2001-09-25 | Normal 180 Day Track |
| S052 | 2000-01-05 | 30-Day Supplement |
| S051 | 1998-03-12 | 30-Day Supplement |
| S050 | 1998-02-20 | 30-Day Supplement |
| S049 | 1997-12-22 | Normal 180 Day Track |
| S048 | 1997-09-16 | Normal 180 Day Track |
| S047 | 1995-05-01 | Special (immediate Track) |
| S046 | 1995-04-27 | Special (immediate Track) |
| S045 | 1994-01-14 | Normal 180 Day Track |
| S044 | 1993-08-02 | Normal 180 Day Track |
| S043 | 1993-08-02 | Normal 180 Day Track |
| S042 | ||
| S041 | 1992-06-30 | Normal 180 Day Track |
| S040 | 1992-06-09 | Normal 180 Day Track |
| S039 | 1992-03-03 | Normal 180 Day Track |
| S038 | 1992-01-16 | Normal 180 Day Track |
| S037 | 1992-01-03 | Normal 180 Day Track |
| S036 | 1991-11-04 | Normal 180 Day Track |
| S035 | 1991-10-29 | Normal 180 Day Track |
| S034 | 1991-03-20 | Normal 180 Day Track |
| S033 | 1991-03-04 | Normal 180 Day Track |
| S032 | 1990-12-31 | 30-Day Supplement |
| S031 | 1990-11-08 | Normal 180 Day Track |
| S030 | 1990-11-06 | Normal 180 Day Track |
| S029 | 1990-10-01 | Normal 180 Day Track |
| S028 | 1990-05-11 | Normal 180 Day Track |
| S027 | ||
| S026 | 1990-03-16 | 30-Day Supplement |
| S025 | 1990-03-12 | 30-Day Supplement |
| S024 | 1990-02-07 | Normal 180 Day Track |
| S023 | 1989-11-30 | Normal 180 Day Track |
| S022 | 1989-11-13 | Normal 180 Day Track |
| S021 | 1989-10-31 | Normal 180 Day Track |
| S020 | 1989-07-27 | Normal 180 Day Track |
| S019 | 1989-07-18 | Normal 180 Day Track |
| S018 | 1989-06-23 | Normal 180 Day Track |
| S017 | 1989-05-18 | Normal 180 Day Track |
| S016 | 1989-05-05 | Normal 180 Day Track |
| S015 | ||
| S014 | 1989-02-16 | Normal 180 Day Track |
| S013 | 1988-12-02 | Normal 180 Day Track |
| S012 | 1988-10-27 | Normal 180 Day Track |
| S011 | 1988-09-01 | Normal 180 Day Track |
| S010 | 1988-08-03 | 30-Day Supplement |
| S009 | ||
| S008 | 1988-07-19 | 30-Day Supplement |
| S007 | 1988-07-01 | Normal 180 Day Track |
| S006 | 1988-06-13 | 30-Day Supplement |
| S005 | 1988-06-02 | Normal 180 Day Track |
| S004 | 1988-06-01 | Normal 180 Day Track |
| S003 | 1988-02-26 | Normal 180 Day Track |
| S002 | 1988-02-03 | Normal 180 Day Track |
| S001 | 1988-01-15 | Normal 180 Day Track |