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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
Classification Namefluid, intraocular
Generic Namefluid, intraocular
Regulation Number886.4275
Applicant
BAUSCH & LOMB
50 technology drive
irvine, CA 92618
PMA NumberP910071
Supplement NumberS008
Date Received01/13/2006
Decision Date02/24/2006
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
REMOVAL OF THE HEAT STERILIZATION SUB-LOT SUFFIX FROM THE LABELING.
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