PMA P080011S147
- Device
- Biofinity Sphere, Biofinity Toric
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S147
- Product code
- LPM
- Decision date
- 2022-08-08
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Installation and qualification of three Gas Chromatography (GC) replacement equipment at the CooperVision Manufacturing Puerto Rico, LLC facility.
Current openFDA PMA Record#
- Device
- Biofinity Sphere, Biofinity Toric
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S147
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2022-08-08
- Decision code
- OK30
- Date received
- 2022-07-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Installation and qualification of three Gas Chromatography (GC) replacement equipment at the CooperVision Manufacturing Puerto Rico, LLC facility.