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 labeling changes including adding to the approved labeling allergan inc. 's destat 4 system and alcon laboratories, inc. 's opti-soak system. No furhter changes will be made in the labeling.
| Device | MENICON SF-P (MELAFOCON A) CONTACT LENS |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | MENICON CO. LTD. |
| Date Received | 1996-01-04 |
| Decision Date | 1996-04-03 |
| PMA | P880098 |
| Supplement | S009 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |