PMA N18033S099

Device: VISTAKON (etafilcon A) Brand Contact Lenses
Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
PMA number: N18033
Supplement: S099
Product code: LPM
Decision date: 2018-07-10
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Modification of the heat seal mechanism used to seal the foil lidstock onto the primary package during 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: S099
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2018-07-10
Decision code: OK30
Date received: 2018-06-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification of the heat seal mechanism used to seal the foil lidstock onto the primary package during the manufacturing process of VISTAKON® (etafilcon A) Brand Contact Lenses.