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 an alternate packaging process where barnes hind(r) comfort care(r) gp wetting and soaking solution is added to the lens shipping case. Lenses will be shipped wet with a storage period of up to 30 days from the date of hydration.
| 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 | 1997-06-30 |
| Decision Date | 1997-08-25 |
| PMA | P880098 |
| Supplement | S010 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| 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 |