PMA P040045S103

Device: VISTAKON (senofilcon A) ACUVUE OASYS Brand Contact Lenses
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S103
Product code: LPM
Decision date: 2019-01-15
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Qualification of an existing production line to produce VISTAKON® (senofilcon A) ACUVUE OASYS® Brand Contact Lenses.

Current openFDA PMA Record#

Device: VISTAKON (senofilcon A) ACUVUE OASYS Brand Contact Lenses
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S103
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2019-01-15
Decision code: OK30
Date received: 2018-12-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of an existing production line to produce VISTAKON® (senofilcon A) ACUVUE OASYS® Brand Contact Lenses.