- Device
- VISTAKON (senofilcon A) Brand Contact Lenses
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- PMA number
- P040045
- Supplement
- S100
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2018-07-30
- Decision code
- OK30
- Date received
- 2018-07-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement sterilizer unit to be used in the manufacturing process of VISTAKON (senofilcon A) Brand Contact Lenses.