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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.
 
DeviceSILICOM(TM) 1000 RETINALTAMPONADE
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantAlcon
6201 S. Fwy.
Mail Drop R7-14
Fort Worth, TX 76134
PMA NumberP950008
Supplement NumberS012
Date Received07/07/2014
Decision Date11/03/2014
Product Code LWL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON RESEARCH, LTD., IN FORT WORTH, TEXAS.
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