PMA P080011S060
- Device
- Biofinity XR Toric
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S060
- Product code
- LPM
- Decision date
- 2017-06-22
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Modification to the surface finish of the male plug used in the manufacturing of Biofinity MTO (Made to Order) XR Toric lenses.
Current openFDA PMA Record#
- Device
- Biofinity XR Toric
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S060
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2017-06-22
- Decision code
- OK30
- Date received
- 2017-05-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the surface finish of the male plug used in the manufacturing of Biofinity MTO (Made to Order) XR Toric lenses.