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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.
Classification Namelens, contact, orthokeratology, overnight
Generic Namerigid gas permeable,contact lens for orthokeratology
Regulation Number886.5916
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).