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 alcon unique-ph multi-purpose solution as an alternate wet shipping solution for the menicon sf-p rigid gas permeable contact lens, labeling changes to reflect the use of alcon unique-ph as a packaging solution and to update the labeling in accordance with recently approved menicon rigid gas permeable contact lens labeling.
| Device | MENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS |
| Classification Name | Lens, Contact (other Material) - Daily |
| Generic Name | Lens, Contact (other Material) - Daily |
| Applicant | MENICON CO. LTD. |
| Date Received | 2002-11-19 |
| Decision Date | 2002-12-10 |
| PMA | P880098 |
| Supplement | S012 |
| Product Code | HQD |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MENICON CO. LTD. 269a Ballardvale St. wilmington, MA 01887 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880098 | Original Filing | |
| S012 | 2002-11-19 | Real-time Process |
| S011 | 2000-06-13 | Normal 180 Day Track |
| S010 | 1997-06-30 | Normal 180 Day Track |
| S009 | 1996-01-04 | Normal 180 Day Track |
| S008 | 1995-05-15 | Special (immediate Track) |
| S007 | ||
| S006 | 1993-03-01 | Normal 180 Day Track |
| S005 | 1991-08-08 | Normal 180 Day Track |
| S004 | 1990-02-13 | Normal 180 Day Track |
| S003 | 1989-12-01 | Normal 180 Day Track |
| S002 | 1989-10-06 | Normal 180 Day Track |
| S001 | 1989-07-24 | Normal 180 Day Track |