- Device
- VISTAKON (senofilcon A) Brand Contact Lenses
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- PMA number
- P040045
- Supplement
- S116
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2021-06-25
- Decision code
- APPR
- Date received
- 2020-06-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the implementation of a new test method for measurement of a leachable component in VISTAKON® (senofilcon A) Brand Contact Lenses.