- Device
- Biomedics 55 Asphere (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Applicant
- The Cooper Companies
- PMA number
- P890023
- Supplement
- S049
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2022-09-23
- Decision code
- OK30
- Date received
- 2022-08-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of Biomedics 55 Asphere lens capability onto existing manufacturing lines at CooperVision Manufacturing Puerto Rico, LLC.