ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses, Biomedics 55 Sphere, Biomedics Toric
FDA premarket approval P890023/S034 · decided 2018-08-01
Approval details
- PMA number
- P890023
- Supplement
- S034
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses, Biomedics 55 Sphere, Biomedics Toric
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2018-06-18
- Decision date
- 2018-08-01
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for a modification to the packaging formulation and process used in the packaging of ocufilcon D Soft (hydrophilic) extended wear contact lenses.
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