PMA N18033S102

Device: VISTAKON (etafilcon A) Brand Contact Lenses
Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
PMA number: N18033
Supplement: S102
Product code: LPM
Decision date: 2019-04-05
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Manufacturer recommended like-for-like replacement part used during the manufacturing process of 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: S102
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2019-04-05
Decision code: OK30
Date received: 2019-03-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturer recommended like-for-like replacement part used during the manufacturing process of VISTAKON® (senofilcon A) and (etafilcon A) Brand Contact Lenses.