Biofinity XR Toric
FDA premarket approval P080011/S057 · decided 2017-04-10
Approval details
- PMA number
- P080011
- Supplement
- S057
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity XR Toric
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2017-03-24
- Decision date
- 2017-04-10
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Use of Biofinity Line 3 for the production of Biofinity XR Toric lenses with a sphere power range of 0.00D to +10.00D and cylinder powers of -2.75D to -4.25D.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.