ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
FDA premarket approval P890023/S039 · decided 2019-11-14
Approval details
- PMA number
- P890023
- Supplement
- S039
- 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
- 2019-10-15
- Decision date
- 2019-11-14
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Installation and validation of two new sterilizers at the CooperVision, Inc., manufacturing facility in Scottsville, New York.
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