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.
Conversion of manufacturing equipment for preference sphere (tetrafilcon a) lenses produced at the coopervision incorporated manufacturing facility in scottsville, new york.
| Device | Preference (tetrafilcon A) Soft (hydrophillic) Contact Lenses |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | COOPERVISION, INC. |
| Date Received | 2017-10-23 |
| Decision Date | 2017-11-16 |
| PMA | N17679 |
| Supplement | S038 |
| Product Code | LPM |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COOPERVISION, INC. 6150 Stoneridge Mall Road suite 370 pleasanton, CA 94588 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17679 | Original Filing | |
| S040 | 2018-06-07 | 30-day Notice |
| S039 | 2018-01-16 | 135 Review Track For 30-day Notice |
| S038 | 2017-10-23 | 30-day Notice |
| S037 | 2017-09-20 | 30-day Notice |
| S036 | 2013-08-19 | 30-day Notice |
| S035 | ||
| S034 | 1999-02-23 | Normal 180 Day Track |
| S033 | ||
| S032 | 1998-02-17 | Normal 180 Day Track |
| S031 | ||
| S030 | 1995-03-29 | 30-Day Supplement |
| S029 | 1995-03-01 | Normal 180 Day Track |
| S028 | 1993-08-20 | Normal 180 Day Track |
| S027 | 1993-07-20 | Normal 180 Day Track |
| S026 | ||
| S025 | 1991-03-21 | Normal 180 Day Track |
| S024 | 1990-12-07 | Normal 180 Day Track |
| S023 | 1990-09-13 | Normal 180 Day Track |
| S022 | 1990-05-03 | Normal 180 Day Track |
| S021 | 1989-07-24 | Normal 180 Day Track |
| S020 | 1989-04-12 | Normal 180 Day Track |
| S019 | 1989-02-22 | Normal 180 Day Track |
| S018 | 1988-05-12 | Special (immediate Track) |
| S017 | 1988-03-24 | Special (immediate Track) |
| S016 | 1987-11-09 | Special (immediate Track) |
| S015 | 1987-10-26 | Normal 180 Day Track |
| S014 | 1987-10-01 | Special (immediate Track) |
| S013 | 1987-09-10 | Normal 180 Day Track |
| S012 | 1986-03-03 | |
| S011 | 1986-01-08 | |
| S010 | 1986-01-06 | |
| S009 | 1985-05-30 | |
| S008 | 1984-12-21 | |
| S007 | 1984-08-07 | |
| S006 | 1984-07-02 | |
| S005 | ||
| S004 | ||
| S003 | 1980-01-08 | |
| S002 | ||
| S001 | 1979-05-01 |