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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 NamePERMLENS
Classification Namelenses, soft contact, extended wear
Generic Nameperfilcon a soft contact lens
Regulation Number886.5925
ApplicantCOOPER LABORATORIES
PMA NumberP780010
Supplement NumberS020
Date Received10/28/1998
Decision Date12/04/1998
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a ten (10) year expiration date for the permalens (perfilcon a) hydrophilic contact lenses. The device, as modified, will be marketed under the trade name as referenced above with no change in the current indications.
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