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.
| Device | TECHNICON-38 POLYMACON HYDROPHILIC LENS |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | WESTCON CONTACT LENS CO., INC. |
| Date Received | 1992-09-16 |
| Decision Date | 1993-02-11 |
| PMA | P900065 |
| Supplement | S003 |
| Product Code | LPL |
| 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 | WESTCON CONTACT LENS CO., INC. 2775 Crossroads Blvd. suite 110 grand Junction, CO 81506 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900065 | Original Filing | |
| S003 | 1992-09-16 | Normal 180 Day Track |
| S002 | ||
| S001 | 1991-08-27 | Normal 180 Day Track |