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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceADATOMED SILICONE OIL OP5000
Classification Namefluid, intraocular
Generic Namefluid, intraocular
Regulation Number886.4275
Applicant
BAUSCH & LOMB
50 technology drive
irvine, CA 92618
PMA NumberP910071
Date Received12/16/1991
Decision Date11/04/1994
Product Code
LWL[ Registered Establishments with LWL ]
Docket Number 95M-0180
Notice Date 07/20/1995
Advisory Committee Ophthalmic
Expedited Review Granted? Yes
Combination Product No
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 
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