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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 5000
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantBAUSCH & LOMB
50 Technology Drive
Irvine, CA 92618
PMA NumberP910071
Supplement NumberS004
Date Received07/08/1997
Decision Date12/24/1997
Product Code LWL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Requested that a Phase IV trial of AdatoSil 5000(TM) no longer be required as a condition of approval for this PMA, and that the current labeling be revised to state more specificaly the role of the physician in determining the use and removal of AdatoSil 5000(TM) silicone oil.
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