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 the five additional finishing laboratories listed in the enclosure to become additional manufacturers and distributors of the contact lenses. Fda also acknowledges your notification of a new adopted usan name for equalens ii (oprifocon a).
| Device | IPAFLUOROFOCON A AND B |
| Classification Name | Lens, Contact (other Material) - Daily |
| Generic Name | Lens, Contact (other Material) - Daily |
| Applicant | POLYMER TECHNOLOGY CORP. |
| Date Received | 1997-09-16 |
| Decision Date | 1997-10-15 |
| PMA | P860022 |
| Supplement | S048 |
| Product Code | HQD |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Other Report |
| 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 |