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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 NameFLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES
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 NumberS045
Date Received12/15/2004
Decision Date01/07/2005
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 
Modification of a specific process of manufacture to reduce the hydration time and improve the comfort for the contact lens user.
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