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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.
 
DeviceSILIKON 1000
Classification Namefluid, intraocular
Generic Namefluid, intraocular
Regulation Number886.4275
Applicant
ALCON
6201 south freeway
mail drop r7-14
fort worth, TX 76134-2099
PMA NumberP950008
Supplement NumberS008
Date Received02/11/2011
Decision Date03/10/2011
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ESTABLISH ISO CLASSIFICATION FOR TWO CONTROLLED ENVIRONMENT AREAS.
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