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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NamePARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY
Classification Namelens, contact, orthokeratology, overnight
Generic Namerigid gas permeable,contact lens for orthokeratology
Regulation Number886.5916
ApplicantPARAGON VISION SCIENCES
PMA NumberP050031
Date Received08/26/2005
Decision Date11/16/2006
Product Code
NUU[ Registered Establishments with NUU ]
Docket Number 06M-0473
Notice Date 11/27/2006
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the paragon z crt (tisilfocon a) rigid gas permeable contact lenses for contact lens corneal refractive therapy. The lenses are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear in the contact lens corneal refractive therapy fitting program for the temporary reduction of myopia up to 6. 00 diopters in eyes with astigmatism up to 1. 75 diopters. The lenses may be disinfected using only a chemical disinfection system. Note: to maintain the contact lens corneal refractive therapy effect of myopia reduction, overnight lens wear must be continued on a prescribed schedule. Failure to do so can affect daily activities (e. G. , night driving), visual fluctuations and changes in intended correction.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 
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