Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
FDA premarket approval P080011/S125 · decided 2021-04-15
Approval details
- PMA number
- P080011
- Supplement
- S125
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2021-03-18
- Decision date
- 2021-04-15
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Introduction of Biofinity XR Toric extended range product to cover additional sphere powers on Biofinity MTO Line 2.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.