PMA P050031S005

Device: Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Rigid Gas Permeable Contact lenses in blue tint
Applicant: CooperVision, Inc.
PMA number: P050031
Supplement: S005
Product code: NUU
Decision date: 2019-07-11
Classification: Lens, Contact, Orthokeratology, Overnight
Generic name: Lens, contact, orthokeratology, overnight
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 Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Rigid Gas Permeable Contact lenses in blue tint
Applicant: CooperVision, Inc.
PMA number: P050031
Supplement: S005
Product code: NUU
Generic name: Lens, contact, orthokeratology, overnight
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.