- Device
- MENICON SF-P (MELAFOCON A) CONTACT LENS
- Applicant
- Menicon Co, Ltd.
- PMA number
- P880098
- Supplement
- S009
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 1996-04-03
- Decision code
- APPR
- Date received
- 1996-01-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.