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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 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.
 
DevicePARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..
Generic NameLens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Road, Suite 500
San Ramon, CA 94583
PMA NumberP870024
Supplement NumberS043
Date Received10/02/2001
Decision Date06/13/2002
Product Code NUU 
Docket Number 02M-0295
Notice Date 07/02/2002
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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