SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS
FDA premarket approval P850077/S023 · decided 1997-05-19
Approval details
- PMA number
- P850077
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1997-04-16
- Decision date
- 1997-05-19
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR AN ALTERNATE MOLDED LENS MANUFACTURING PROCESS FOR A MULTIFOCAL LENS DESIGN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNSOFT MULTIPLES(TM) AND IS INDICATED FOR DIALY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENS IS INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES THAT ARE PRESBYOPIC, WITH OR WITHOUT ASSOCIATED AMETROPIA. THE
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