PMA P780007S052

Device
POLYMACON EXTENDED WEAR LENSES
Applicant
CooperVision, Inc.
PMA number
P780007
Supplement
S052
Product code
LPM
Decision date
2013-12-13
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
MANUFACTURING CHANGE TO ADD A NEW QUALITY TEST FOR MANUFACTURING.

Current openFDA PMA Record#

Device
POLYMACON EXTENDED WEAR LENSES
Applicant
CooperVision, Inc.
PMA number
P780007
Supplement
S052
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2013-12-13
Decision code
OK30
Date received
2013-11-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MANUFACTURING CHANGE TO ADD A NEW QUALITY TEST FOR MANUFACTURING.