ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
FDA premarket approval P890023/S037 · decided 2019-03-26
Approval details
- PMA number
- P890023
- Supplement
- S037
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2019-02-26
- Decision date
- 2019-03-26
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Manufacture of Biomedics Toric lenses in the plus power range at the CooperVision facility in Scottsville, New York.
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