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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 NumberS013
Date Received12/29/2010
Decision Date01/24/2012
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ADDITION OF A HEAT SHRINK TUBE TO THE PRIMARY PACKAGING FOR THE DEVICE TO ASSURE A TIGHTER FIT BETWEEN THE LUER ADAPTER AND THE SYRINGE BARREL BODY.
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