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 ten (10) year expiration date for the permalens (perfilcon a) hydrophilic contact lenses. The device, as modified, will be marketed under the trade name as referenced above with no change in the current indications.
| Device | PERMLENS |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | COOPERVISION, INC. |
| Date Received | 1998-10-28 |
| Decision Date | 1998-12-04 |
| PMA | P780010 |
| Supplement | S020 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |