ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
FDA premarket approval P890023/S033 · decided 2018-09-07
Approval details
- PMA number
- P890023
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2018-06-15
- Decision date
- 2018-09-07
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval to request a minor modification to the lens edge form.
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