Biofinity XR Toric (comfilcon A ) Soft (Hydrophilic) Extended Wear Contact Lenses
FDA premarket approval P080011/S063 · decided 2017-11-22
Approval details
- PMA number
- P080011
- Supplement
- S063
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity XR Toric (comfilcon A ) Soft (Hydrophilic) Extended Wear Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2017-10-26
- Decision date
- 2017-11-22
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Introduction of a new Rapid Readout Biological Indicators (RRBIs) incubator and the reduction in the number of RRBIs.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.