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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.
 
DeviceADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S)
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantBausch & Lomb
50 Technology Dr.
Irvine, CA 92618
PMA NumberP910071
Supplement NumberS007
Date Received09/06/2005
Decision Date12/16/2005
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 1) CHANGE OF THE TIP CAP OF THE 10 ML HYPAC SCF SYRINGE FROM CONTAINING DRY NATURAL RUBBER MATERIAL TO LATEX-FREE MATERIAL AND 2) REVISION OF THE LABELING TO REMOVE THE "DRY NATURAL RUBBER" STATEMENT.
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