Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
FDA premarket approval P890023/S046 · decided 2020-12-10
Approval details
- PMA number
- P890023
- Supplement
- S046
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2020-09-18
- Decision date
- 2020-12-10
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Addition of a second supplier of a raw material, including changes to the raw material specification, for the Biomedics 55 (ocufilcon D) soft (hydrophilic) contact lenses for extended wear.
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