PMA P080011S061
- Device
- Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S061
- Product code
- LPM
- Decision date
- 2017-08-07
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Change to the injection molding machine cycle time for Biofinity Sphere (comfilcon A) lenses.
Current openFDA PMA Record#
- Device
- Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S061
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2017-08-07
- Decision code
- OK30
- Date received
- 2017-07-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the injection molding machine cycle time for Biofinity Sphere (comfilcon A) lenses.