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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.
 
DeviceRIGID GAS PERMEABLE CONTACT LENS
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Namelens,contact(rigid gas permeable)-extended wear
Regulation Number886.5916
Applicant
PARAGON VISION SCIENCES
947 east impala ave.
mesa, AZ 85204
PMA NumberP870024
Supplement NumberS047
Date Received06/17/2009
Decision Date12/11/2009
Product Code
MWL[ Registered Establishments with MWL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR PACKAGING THE CONTACT LENSES IN A DIFFERENT MULTIPURPOSE SOLUTION WHEN SHIPPED WET.
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