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 | SGP II - F CONTACT LENS |
| Generic Name | Lens, Contact (other Material) - Daily |
| Applicant | THE LIFESTYLE CO., INC. |
| Date Received | 1991-04-11 |
| Decision Date | 1991-05-06 |
| PMA | P900001 |
| Supplement | S002 |
| Product Code | HQD |
| 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 | THE LIFESTYLE CO., INC. 712 Ginesi Dr. morganville, NJ 07751 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900001 | Original Filing | |
| S009 | 1993-05-11 | Normal 180 Day Track |
| S008 | 1992-11-06 | Normal 180 Day Track |
| S007 | 1992-09-23 | Normal 180 Day Track |
| S006 | 1992-08-19 | Normal 180 Day Track |
| S005 | 1992-03-04 | Normal 180 Day Track |
| S004 | 1991-12-23 | Normal 180 Day Track |
| S003 | 1991-07-16 | Normal 180 Day Track |
| S002 | 1991-04-11 | Normal 180 Day Track |
| S001 | 1991-02-08 | 30-Day Supplement |
| Device ID | PMA | Supp |
|---|---|---|
| 00830002003019 | P900001 | 001 |