PMA P080011S069
- Device
- comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S069
- Product code
- LPM
- Decision date
- 2018-11-23
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Approval for the harmonization of calibration procedures.
Current openFDA PMA Record#
- Device
- comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S069
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2018-11-23
- Decision code
- APPR
- Date received
- 2018-01-16
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the harmonization of calibration procedures.