- Device
- Biomedics 55 Asphere
- Applicant
- The Cooper Companies
- PMA number
- P890023
- Supplement
- S048
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2022-05-24
- Decision code
- OK30
- Date received
- 2022-04-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of Biomedics 55 Asphere lens capability to the Low Volume Automation (LVA1) manufacturing line at the CooperVision, Inc. facility in Scottsville, New York.