PMA P040045S107

Device
Vistakon (senofilcon A) Brand Contact Lenses
Applicant
Vistakon, Division of Johnson & Johnson Vision Car
PMA number
P040045
Supplement
S107
Product code
LPM
Decision date
2019-05-17
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Like-for-like replacement part used during the manufacturing process of VISTAKON (senofilcon A) and (etafilcon A) 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
S107
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2019-05-17
Decision code
OK30
Date received
2019-04-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Like-for-like replacement part used during the manufacturing process of VISTAKON (senofilcon A) and (etafilcon A) Contact Lenses.