PMA P080011S084
- Device
- Biofinity (Comfilcon A)
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S084
- Product code
- LPM
- Decision date
- 2018-11-30
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Introduction and validation of a new labeling line.
Current openFDA PMA Record#
- Device
- Biofinity (Comfilcon A)
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S084
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2018-11-30
- Decision code
- OK30
- Date received
- 2018-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction and validation of a new labeling line.