METHAFILCON A
FDA premarket approval P850079/S037 · decided 2000-09-25
Approval details
- PMA number
- P850079
- Supplement
- S037
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- METHAFILCON A
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2000-08-16
- Decision date
- 2000-09-25
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- APPROVAL FOR THE FREQUENCY COLORS CONTACT LENSES IN PHERICAL, ASPHERIC AND TORIC CONFIGURATIONS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES FREQUENCY COLORS, FREQUENCY ASPHERIC COLORS AND FREQUENCY TORIC COLORS (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR. THE FREQUENCY COLORS, FREQUENCY ASPHERIC COLORS ARE INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THEY ARE
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