PMA P850079S071

Device
HYDRASOFT CONTACT LENS
Applicant
CooperVision, Inc.
PMA number
P850079
Supplement
S071
Product code
LPM
Decision date
2017-01-17
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Acceptance of validation of dry molding line X to manufacture Frequency 55 Aspheric Z1 methafilcon A contact lenses.

Current openFDA PMA Record#

Device
HYDRASOFT CONTACT LENS
Applicant
CooperVision, Inc.
PMA number
P850079
Supplement
S071
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2017-01-17
Decision code
OK30
Date received
2016-12-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Acceptance of validation of dry molding line X to manufacture Frequency 55 Aspheric Z1 methafilcon A contact lenses.