Biomedics Toric (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
FDA premarket approval P890023/S047 · decided 2020-10-16
Approval details
- PMA number
- P890023
- Supplement
- S047
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biomedics Toric (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2020-09-25
- Decision date
- 2020-10-16
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Addition of Biomedics Toric lens capability to the LVA3 manufacturing cell.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.