HYDRONICS 60 UV IMT CONTACT LENS FOR EXTENDED WEAR
FDA premarket approval P890023/S011 · decided 2002-01-16
Approval details
- PMA number
- P890023
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HYDRONICS 60 UV IMT CONTACT LENS FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2001-07-20
- Decision date
- 2002-01-16
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE HYDROGENICS 60 (OCUFILCON F) UV IN-MONOMER TINT CONTACT LENS INDICATED FOR EXTENDED WEAR (UP TO 7 DAYS / 6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATIONS: SPHERICAL: HYDROGENICS 60 (OCUFILCON F) UV BLOCKING CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) A
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