Biomedics Toric/ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
FDA premarket approval P890023/S032 · decided 2018-06-27
Approval details
- PMA number
- P890023
- Supplement
- S032
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biomedics Toric/ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2018-04-05
- Decision date
- 2018-06-27
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for a manufacturing site located at CooperVision, Inc., 711 North Road, Scottsville, New York.
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