PMA P080011S072
- Device
- Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S072
- Product code
- LPM
- Decision date
- 2018-03-29
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Addition of IGM Resins as a new supplier in the manufacture of Biofinity (comfilcon A) soft contact lenses.
Current openFDA PMA Record#
- Device
- Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S072
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2018-03-29
- Decision code
- OK30
- Date received
- 2018-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of IGM Resins as a new supplier in the manufacture of Biofinity (comfilcon A) soft contact lenses.