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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
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantALCON
6201 SOUTH FREEWAY
MAIL DROP R7-14
FORT WORTH, TX 76134-2099
PMA NumberP950008
Supplement NumberS006
Date Received12/15/2003
Decision Date12/22/2003
Product Code LWL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE SPECIFICATION FOR THE FINISHED PRODUCT VISCOSITY RANGE, I.E., FROM THE RANGE OF 900 TO 1200 CS TO THE RANG OF 900 TO 1250 CS.
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