PMA P080011S124
- Device
- Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (HydrophlHc) Contact Lenses for Extended Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S124
- Product code
- LPM
- Decision date
- 2021-04-06
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Modification of automated inspection system distortion tolerance.
Current openFDA PMA Record#
- Device
- Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (HydrophlHc) Contact Lenses for Extended Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S124
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2021-04-06
- Decision code
- OK30
- Date received
- 2021-03-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of automated inspection system distortion tolerance.