PMA P040045S112

Device: VISTAKON (senofilcon A) Brand Contact Lenses
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S112
Product code: LPM
Decision date: 2019-12-18
Generic name: Lenses, soft contact, extended wear
Approval order statement: Modification to the processing aids used during the post-hydration process for the manufacture of VISTAKON® (senofilcon A) Brand Contact Lenses.

Current openFDA PMA Record#

Device: VISTAKON (senofilcon A) Brand Contact Lenses
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S112
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2019-12-18
Decision code: OK30
Date received: 2019-11-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification to the processing aids used during the post-hydration process for the manufacture of VISTAKON® (senofilcon A) Brand Contact Lenses.