Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Rigid Gas Permeable Contact lenses in blue tint

Lens, Contact, Orthokeratology, Overnight

FDA Premarket Approval P050031 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval of site change.

• Device: Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Rigid Gas Permeable Contact lenses in blue tint
• Classification Name: Lens, Contact, Orthokeratology, Overnight
• Generic Name: Lens, Contact, Orthokeratology, Overnight
• Applicant: PARAGON VISION SCIENCES
• Date Received: 2019-03-13
• Decision Date: 2019-07-11
• PMA: P050031
• Supplement: S005
• Product Code: NUU
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: PARAGON VISION SCIENCES 947 East Impala Ave. mesa, AZ 85204

Supplemental Filings

Supplement Number	Date	Supplement Type
P050031		Original Filing
S009	2022-04-15	30-day Notice
S008
S007	2020-08-05	30-day Notice
S006	2020-08-04	30-day Notice
S005	2019-03-13	Normal 180 Day Track No User Fee
S004
S003	2019-02-04	Real-time Process
S002
S001	2010-10-25	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
B22222	P050031	000
B22221	P050031	000