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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 NumberS013
Date Received06/24/2016
Decision Date07/18/2016
Product Code LWL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of a new biological indicator to be used as an alternate process challenge device (PCD) for terminal sterilization of SILIKON 1000.
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