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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
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantBausch & Lomb
50 Technology Dr.
Irvine, CA 92618
PMA NumberP910071
Supplement NumberS010
Date Received07/11/2007
Decision Date12/12/2007
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 A PACKAGING CHANGE WHICH INVOLVES THE ADDITION OF A RIGID TIP CAP TO THE 10 CC GLASS SYRINGE PACKAGING CONFIGURATION TO INCORPORATE A RIGID POLYPROPYLENE HOUSING AROUND THE ELASTOMER SEAL.
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