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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 NamePOLYMACON SOFT (HYDROPHILIC) CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPER VISION, INC.
PMA NumberP780007
Supplement NumberS044
Date Received10/23/2008
Decision Date11/21/2008
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 
Migration to an in-blister hydration process for the polymacon 38 lenses.
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