PMA P870024S051

Device
Paragon CRT (paflufocon B), Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) and Paragon RG-4 (paflu
Applicant
CooperVision, Inc.
Product code
MWL
Decision date
2019-07-11
Generic name
Lens, contact (rigid gas permeable), extended wear
Approval order statement
Approval for a manufacturing site located at Paragon Vision Sciences, Inc., 2120 W. Guadalupe Rd. Suite #112, Gilbert, Arizona 85233.

Current openFDA PMA Record#

Device
Paragon CRT (paflufocon B), Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) and Paragon RG-4 (paflu
Applicant
CooperVision, Inc.
PMA number
P870024
Supplement
S051
Product code
MWL
Generic name
Lens, contact (rigid gas permeable), extended wear
Decision date
2019-07-11
Decision code
APPR
Date received
2019-03-13
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Paragon Vision Sciences, Inc., 2120 W. Guadalupe Rd. Suite #112, Gilbert, Arizona 85233.