- Device
- SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS
- Applicant
- CooperVision, Inc.
- PMA number
- P850077
- Supplement
- S024
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 1997-06-20
- Decision code
- APPR
- Date received
- 1997-05-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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 (HYDROPHILIC) CONTACT LENSES, SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) APHAKIC EXTENDED WEAR CONTACT LENSES, SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) APHAKIC EXTENDED WEAR CONTACT LENS, AND SUNSOFT MULTIFOCAL(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES. THE INDICATIONS AND SHELF-LIFE FOR THESE DEVICES REMAIN UNCHANGED FROM THAT PREVIOUSLY APPROVED.