|
Device | MENICON SF-P (MELAFOCON A) CONTACT LENS |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | MENICON CO. LTD. 269A BALLARDVALE ST. WILMINGTON, MA 01887 |
PMA Number | P880098 |
Supplement Number | S009 |
Date Received | 01/04/1996 |
Decision Date | 04/03/1996 |
Withdrawal Date
|
05/05/2008 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |