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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 NumberS001
Date Received06/19/2000
Decision Date07/11/2000
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 MODIFICATION TO THE MOLECULAR WEIGHT SPECIFICATION RANGE FROM 38,000-48,000 DALTONS TO 36,000-48,000 DALTONS.
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