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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 NameVISIONS MADE WITH PARAGON HDS (PAFLUFOCON B)
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Nameextended wear, rigid gas permeable, contact lens
Regulation Number886.5916
ApplicantPARAGON OPTICAL CO.
PMA NumberP870024
Supplement NumberS042
Date Received07/12/1999
Decision Date01/31/2000
Product Code
MWL[ Registered Establishments with MWL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval is for wet shipping and up to 30 day storage of the extended wear rigid gas permeable lenses in alcon wetting, soakig, conditioning and disinfecting solution id 84392.
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