Biofinity XR Toric (comfilcon A)
FDA premarket approval P080011/S087 · decided 2019-10-25
Approval details
- PMA number
- P080011
- Supplement
- S087
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity XR Toric (comfilcon A)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2018-12-27
- Decision date
- 2019-10-25
- Days to decision
- 302 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for the use of autoclave Getinge C to provide back up autoclave capacity for lathing produced products in the MTO (Made to Order) Business Unit at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.