PMA N18033S100

Device: VISTAKON (etafilcon A) Brand Contact Lenses
Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
PMA number: N18033
Supplement: S100
Product code: LPM
Decision date: 2018-10-03
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Addition of an alternate test method for use of measuring primary packages for VISTAKON® (senofilcon A) and (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: S100
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2018-10-03
Decision code: OK30
Date received: 2018-09-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate test method for use of measuring primary packages for VISTAKON® (senofilcon A) and (etafilcon A) brand contact lenses.