CLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR
FDA premarket approval P850079/S047 · decided 2010-05-03
Approval details
- PMA number
- P850079
- Supplement
- S047
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2009-12-28
- Decision date
- 2010-05-03
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- APPROVAL FOR THE TRADE NAME CLEAR SOFT. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME CLEAR SOFT AND IS INDICATED FOR:CLEAR SOFT SPHERE (METHAFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF AMETROPIA (MYOPIA OR HYPEROPIA) IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS. THE LENSES MAY BE WORN BYPERSONS WHO EXHIBIT ASTIGMATISM OF -2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.CLEAR SOFT TORIC (
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