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 for wet shipping, with storage up to 30 days, of the boston equalens, equalens ii and boston orthokeratology shaping rigid gas permeable contact lenses in boston simplus multi-action solution.
| Device | BOSTON EQUALENS (ITAFLUOROFOCON A) RIGID GAS PERMEABLE CONTACT LENS, EQUALENS 2 (OPRIFOCON A) RIGID GAS PERMEARABLE 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 | 2008-01-31 |
| Decision Date | 2008-02-21 |
| PMA | P860022 |
| Supplement | S057 |
| Product Code | MWL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |