PMA P080011S057
- Device
- Biofinity XR Toric
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S057
- Product code
- LPM
- Decision date
- 2017-04-10
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order 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.
Current openFDA PMA Record#
- Device
- Biofinity XR Toric
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S057
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2017-04-10
- Decision code
- OK30
- Date received
- 2017-03-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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.