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 reduction of the incubation tiem of the biological indicator used in the lens sterilization process to forty-eight hours.
| Device | VANTAGE (TETRAFILCON A ) CONTACT LENS |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | COOPERVISION, INC. |
| Date Received | 1995-03-01 |
| Decision Date | 1995-07-28 |
| PMA | N17679 |
| Supplement | S029 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location 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 |