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 | NOVALENS (ROSILFOCON A) |
| Generic Name | Lens, Contact (other Material) - Daily |
| Applicant | OCUTEC CORPORATION, INC. |
| Date Received | 1992-10-16 |
| Decision Date | 1993-09-02 |
| PMA | P890058 |
| Supplement | S010 |
| 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 | OCUTEC CORPORATION, INC. 2700-200 Gateway Center Blvd. morrisville, NC 27560 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890058 | Original Filing | |
| S012 | 1993-04-07 | Normal 180 Day Track |
| S011 | 1993-03-17 | Normal 180 Day Track |
| S010 | 1992-10-16 | Normal 180 Day Track |
| S009 | 1991-05-08 | Normal 180 Day Track |
| S008 | 1991-03-07 | Normal 180 Day Track |
| S007 | 1991-02-27 | Normal 180 Day Track |
| S006 | 1990-12-05 | 30-Day Supplement |
| S005 | 1990-09-11 | 30-Day Supplement |
| S004 | 1990-10-16 | Normal 180 Day Track |
| S003 | 1990-09-11 | 30-Day Supplement |
| S002 | 1990-08-27 | 30-Day Supplement |
| S001 | 1990-04-27 | Normal 180 Day Track |