PMA N18033S105

Device: Vistakon (etafilcon A) Brand Contact Lenses
Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
PMA number: N18033
Supplement: S105
Product code: LPM
Decision date: 2019-06-07
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Validation of an existing production line currently producing extended wear VISTAKON (etafilcon A) Brand Contact Lenses with changeover capability between an existing 510(k) VISTAKON etafilcon A contact lens design.

Current openFDA PMA Record#

Device: Vistakon (etafilcon A) Brand Contact Lenses
Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
PMA number: N18033
Supplement: S105
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2019-06-07
Decision code: OK30
Date received: 2019-05-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Validation of an existing production line currently producing extended wear VISTAKON (etafilcon A) Brand Contact Lenses with changeover capability between an existing 510(k) VISTAKON etafilcon A contact lens design.