PMA P080011
- Device
- BIOFINITY (COMFILCON A)
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S153
- Product code
- LPM
- Decision date
- 2026-09-02
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- introduction of a new Density Meter at the Juana Diaz, Puerto Rico facility
Current openFDA PMA Record#
- Device
- BIOFINITY (COMFILCON A)
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S204
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2026-09-02
- Decision code
- OK30
- Date received
- 2026-08-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introduction of a new Density Meter at the Juana Diaz, Puerto Rico facility