PMA N18033S104

Device: Vistakon (etafilcon A) Brand Contact Lenses
Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
PMA number: N18033
Supplement: S104
Product code: LPM
Decision date: 2019-05-29
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Replacement of a steam sterilizer unit that is to be used in the manufacturing process of VISTAKON® (etafilcon A) Brand Contact Lenses.

Current openFDA PMA Record#

Device: Vistakon (etafilcon A) Brand Contact Lenses
Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
PMA number: N18033
Supplement: S104
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2019-05-29
Decision code: OK30
Date received: 2019-05-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of a steam sterilizer unit that is to be used in the manufacturing process of VISTAKON® (etafilcon A) Brand Contact Lenses.