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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameADATO SIL-O1 5000 SILICONE OIL
Classification Namefluid, intraocular
Generic Namesilicone oil
Regulation Number886.4275
ApplicantBAUSCH & LOMB, INC.
PMA NumberP910071
Supplement NumberS014
Date Received08/10/2012
Decision Date08/31/2012
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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