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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.
Classification Namelenses, soft contact, extended wear
Generic Namecomfilcon a soft (hydrophilic) contact lenses for extended wear
Regulation Number886.5925
PMA NumberP080011
Supplement NumberS040
Date Received10/19/2015
Decision Date11/06/2015
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 
Manufacturing change to modify the lens transfer process for the manufacture of the biofinity (comfilcon a) toric contact lenses approved under the original pma.