PMA P040045S110

Device: VISTAKON (senofilcon A) - ACUVUE OASYS for Astigmatism Brand Contact Lenses
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S110
Product code: LPM
Decision date: 2019-09-26
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Modifications of process conditions for steps in the manufacturing process of VISTAKON® (senofilcon A) – ACUVUE OASYS® for Astigmatism Brand Contact Lenses.

Current openFDA PMA Record#

Device: VISTAKON (senofilcon A) - ACUVUE OASYS for Astigmatism Brand Contact Lenses
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S110
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2019-09-26
Decision code: OK30
Date received: 2019-08-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modifications of process conditions for steps in the manufacturing process of VISTAKON® (senofilcon A) – ACUVUE OASYS® for Astigmatism Brand Contact Lenses.