|Trade Name||MENICON SF-P (MELAFOCON A) CONTACT LENS|
|Classification Name||lenses, soft contact, extended wear|
|Applicant||MENICON U.S.A., INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| postapproval protocol or modification to a protocol|
|Expedited Review Granted?|| No|
|Approval Order Statement |
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.