SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS
FDA premarket approval P850077/S024 · decided 1997-06-20
Approval details
- PMA number
- P850077
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1997-05-07
- Decision date
- 1997-06-20
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPOVAL FOR CONSOLIDATED AND REFORMATEED LABELING FOR THE ECLIPSE, SUNFLEX, TORIC 15.0, REVOLUTION, SPORTSOFT, APHAKIC, AND MULTIFOCAL LENSES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ECLIPSE(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, TORIC 15.0(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, SUNFLEX(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, REVOLUTION (TM) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, SPORTSOFT(R) (METHAFILCON A) SOFT (HYD
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