PMA N18033S108

Device
VISTAKON (etafilcon A) Brand Contact Lenses
Applicant
Vistakon, Johnson & Johnson Vision Products, Inc.
PMA number
N18033
Supplement
S108
Product code
LPM
Decision date
2020-11-19
Generic name
Lenses, soft contact, extended wear
Approval order statement
Removal of a redundant in-process test used during the manufacture 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
S108
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2020-11-19
Decision code
OK30
Date received
2020-10-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Removal of a redundant in-process test used during the manufacture of VISTAKON (senofilcon A) and (etafilcon A) Brand Contact Lenses.