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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 S. Fwy.
Mail Drop R7-14
Fort Worth, TX 76134
PMA NumberP950008
Supplement NumberS002
Date Received01/22/2001
Decision Date02/08/2001
Product Code LWL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGE OF STOPPER FOR THE CONTAINER/CLOSURE SYSTEM FOR SILIKON(TM) 1000.
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