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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-O1 5000 SILICONE OIL
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantBAUSCH & LOMB
50 Technology Drive
Irvine, CA 92618
PMA NumberP910071
Supplement NumberS014
Date Received08/10/2012
Decision Date08/31/2012
Product Code LWL 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE LABELING CHANGES TO YOUR DIRECTIONS FOR USE (DFU). THE DFU WAS REVISED TO INCLUDE SAFETY INFORMATION REGARDING THE USE OF CO2 LASERS IN INSTANCES WHERE SILICONE OIL MAY HAVE MIGRATED OUT OF THE EYE AND FORMED LESIONS IN THE CONJUCTIVA OR EYELID.
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