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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 RIGID GAS PERMEABLE CONTACT LENS (PAFLUFOCON C) AND PARAGON RIGID GAS PERMEABLE CONTACT LENS (PAFLUFOCON B)
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 NumberS046
Date Received03/30/2009
Decision Date04/29/2009
Product Code
MWL[ Registered Establishments with MWL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the manufacturing materials.
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