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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Nameextended wear, rigid gas permeable, contact lens
Regulation Number886.5916
ApplicantPARAGON VISION SCIENCES
PMA NumberP870024
Supplement NumberS043
Date Received10/02/2001
Decision Date06/13/2002
Product Code
MWL[ Registered Establishments with MWL ]
Docket Number 02M-0295
Notice Date 07/02/2002
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the following devices and indications: the paragon crt (paflufocon b) and paragon crt 100 (paglufocon d) rigid gas permeable contact lenses for corneal refractive therapy are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear in a contact lenses 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. The paragon quadra rg (paflufocon b) and paragon quadra rg 100 (paflufocon d) rigid gas permeable contact lenses for corneal refractive therapy are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear in a contact lens corneal refractive therapy fitting program for the temporary reduction of myopia up to 3. 00 diopters in eyes with astigmatism up to 1. 50 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
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