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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 LENS
Classification Namelens, contact, orthokeratology, overnight
Generic Namerigid gas permeable,contact lens for orthokeratology
Regulation Number886.5916
ApplicantPARAGON VISION SCIENCES
PMA NumberP050031
Supplement NumberS001
Date Received10/25/2010
Decision Date07/28/2014
Product Code
NUU[ Registered Establishments with NUU ]
Advisory Committee Ophthalmic
Clinical Trials NCT01272271
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling update to the package insert and patient information booklet to include the results from a section 522 postmarket surveillance study (pas).
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