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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePERMLENS
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
COOPERVISION, INC.
6150 stoneridge mall road
suite 500
pleasanton, CA 94588
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 - indications/instructions/shelf life/tradename
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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