FREQUENCY MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND TINTED)
FDA premarket approval P850079/S038 · decided 2001-07-25
Approval details
- PMA number
- P850079
- Supplement
- S038
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FREQUENCY MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND TINTED)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2001-06-01
- Decision date
- 2001-07-25
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- APPROVAL FOR THE FREQUENCY MULTIFOCAL (METHAFILCONA) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND TINTED). THE LENSES 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 INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES WITH MYOPIA OR HYPEROPIA AND ARE PRESBYOPIC. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00
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