PMA P080011S136
- Device
- Biofinity Sphere, Biofinity Toric
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S136
- Product code
- LPM
- Decision date
- 2021-12-10
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Installation and qualification of two new lab equipment at the CooperVision facility located in Juana Diaz, Puerto Rico.
Current openFDA PMA Record#
- Device
- Biofinity Sphere, Biofinity Toric
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S136
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2021-12-10
- Decision code
- OK30
- Date received
- 2021-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Installation and qualification of two new lab equipment at the CooperVision facility located in Juana Diaz, Puerto Rico.