PMA P080011S107
- Device
- Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S107
- Product code
- LPM
- Decision date
- 2020-07-28
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Hardware and software updates to an existing autoclave at the CooperVision Manufacturing facility.
Current openFDA PMA Record#
- Device
- Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S107
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2020-07-28
- Decision code
- OK30
- Date received
- 2020-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Hardware and software updates to an existing autoclave at the CooperVision Manufacturing facility.