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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 NameBIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPER VISION, INC.
PMA NumberP780007
Supplement NumberS045
Date Received04/15/2011
Decision Date05/13/2011
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Utilize the dye penetration test method for testing package integrity.
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