Note: 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. |
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Device | Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Rigid Gas Permeable Contact lenses in blue tint |
Generic Name | Lens, contact, orthokeratology, overnight |
Applicant | CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 |
PMA Number | P050031 |
Supplement Number | S005 |
Date Received | 03/13/2019 |
Decision Date | 07/11/2019 |
Product Codes |
MWL NUU |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at Paragon Vision Sciences, Inc., 2120 W. Guadalupe Rd. Suite #112, Gilbert, Arizona 85233. |
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