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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 NamePERMALENS (PERFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Nameperfilcon a soft contact lens
Regulation Number886.5925
ApplicantCOOPER LABORATORIES
PMA NumberP780010
Supplement NumberS022
Date Received04/18/2001
Decision Date11/16/2001
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in initiator for the referenced devices manufactured at an alternate manufacturing site located in coopervision, huntington beach, california.
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