HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
FDA premarket approval P890023/S016 · decided 2004-09-24
Approval details
- PMA number
- P890023
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2004-08-18
- Decision date
- 2004-09-24
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR A MINOR DESIGN CHANGE TO INCORPORATE THE ASPHERIC VERSION OF THE LENS; A MINOR EDGE CONFIGURATION CHANGE; AND MINOR LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR AND IS INDICATED AS FOLLOWS: HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NOT-APHAKIC, NON-DISEASED EYES
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