PMA P040045S097

Device
Vistakon (Senofilcon A) Brand Contact Lenses
Applicant
Vistakon, Division of Johnson & Johnson Vision Car
PMA number
P040045
Supplement
S097
Product code
LPM
Decision date
2018-05-04
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Addition of an alternate test method for finished product release for VISTAKON (senofilcon A) Brand Contact Lenses.

Current openFDA PMA Record#

Device
Vistakon (Senofilcon A) Brand Contact Lenses
Applicant
Vistakon, Division of Johnson & Johnson Vision Car
PMA number
P040045
Supplement
S097
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2018-05-04
Decision code
OK30
Date received
2018-04-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an alternate test method for finished product release for VISTAKON (senofilcon A) Brand Contact Lenses.