Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints

FDA Premarket Approval P050031 S007

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

Addition of a new laser machine to engrave the lenses.

DeviceParagon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints
Generic NameLens, Contact, Orthokeratology, Overnight
ApplicantPARAGON VISION SCIENCES
Date Received2020-08-05
Decision Date2020-08-31
PMAP050031
SupplementS007
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address PARAGON VISION SCIENCES 947 East Impala Ave. mesa, AZ 85204

Supplemental Filings

Supplement NumberDateSupplement Type
P050031Original Filing
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

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