- Device
- Biofinity Sphere and Biofinity XR Sphere, Biofinity Energys; Biofinity Toric and Biofinity XR Toric; Biofinity Multifoca
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S078
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2018-08-09
- Decision code
- OK30
- Date received
- 2018-07-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification in the Quality Control sampling regime for Biofinity lenses.