FDA.reportPublic FDA data

PMA P870024S053

Device
Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin
Applicant
CooperVision, Inc.
PMA number
P870024
Supplement
S053
Product code
NUU
Decision date
2020-04-20
Generic name
Lens, contact, orthokeratology, overnight
Approval order statement
Software update for generating lathe cutting files for Paragon CRT®100 (paflufocon D) and Paragon CRT Dual Axis® (paflufocon D) Rigid Gas Permeable contact lenses in clear and tints.

Current openFDA PMA Record#

Device
Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin
Applicant
CooperVision, Inc.
PMA number
P870024
Supplement
S053
Product code
NUU
Generic name
Lens, contact, orthokeratology, overnight
Decision date
2020-04-20
Decision code
OK30
Date received
2020-03-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Software update for generating lathe cutting files for Paragon CRT®100 (paflufocon D) and Paragon CRT Dual Axis® (paflufocon D) Rigid Gas Permeable contact lenses in clear and tints.