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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 NumberS010
Date Received06/11/2013
Decision Date07/15/2013
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR LABELING MODIFICATIONS TO THE SILIKON 1000 OIL DIRECTIONS FOR USE.
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