PMA P870024S052

Device
FluoroPerm 92, FluoroPerm 60, FluoroPerm 30, FluoroPerm 151, HDS and HDS 100
Applicant
CooperVision, Inc.
PMA number
P870024
Supplement
S052
Product code
MWL
Decision date
2019-07-03
Classification
Lens, Contact (rigid Gas Permeable), Extended Wear
Generic name
Lens, contact (rigid gas permeable), extended wear
Approval order statement
Removal of a quality control batch release test.

Current openFDA PMA Record#

Device
FluoroPerm 92, FluoroPerm 60, FluoroPerm 30, FluoroPerm 151, HDS and HDS 100
Applicant
CooperVision, Inc.
PMA number
P870024
Supplement
S052
Product code
MWL
Generic name
Lens, contact (rigid gas permeable), extended wear
Decision date
2019-07-03
Decision code
OK30
Date received
2019-06-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Removal of a quality control batch release test.