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 a change in initiator for the referenced devices manufactured at an alternate manufacturing site located in coopervision, huntington beach, california.
| Device | PERMALENS (PERFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | COOPERVISION, INC. |
| Date Received | 2001-04-18 |
| Decision Date | 2001-11-16 |
| PMA | P780010 |
| Supplement | S022 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Express Gmp Supplement |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COOPERVISION, INC. 6150 Stoneridge Mall Road suite 500 pleasanton, CA 94588 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P780010 | Original Filing | |
| S022 | 2001-04-18 | Normal 180 Day Track |
| S021 | 1999-04-19 | Normal 180 Day Track |
| S020 | 1998-10-28 | Real-time Process |
| S019 | 1991-12-05 | Normal 180 Day Track |
| S018 | 1989-07-24 | Normal 180 Day Track |
| S017 | 1989-07-24 | Normal 180 Day Track |
| S016 | 1989-04-12 | Normal 180 Day Track |
| S015 | 1988-04-28 | Special (immediate Track) |
| S014 | 1985-07-11 | |
| S013 | 1983-11-18 | |
| S012 | 1983-05-24 | |
| S011 | 1983-05-16 | |
| S010 | 1983-04-18 | |
| S009 | ||
| S008 | 1980-12-29 | Normal 180 Day Track |
| S007 | ||
| S006 | ||
| S005 | ||
| S004 | ||
| S003 | ||
| S002 | 1979-10-26 | |
| S001 |