- Device
- VISTAKON (etafilcon A) Brand Contact Lenses
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- PMA number
- N18033
- Supplement
- S107
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2020-06-01
- Decision code
- OK30
- Date received
- 2020-05-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an in-process control point during the manufacture of VISTAKON (senofilcon A) and (etafilcon A) Brand Contact Lenses.