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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-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S)
Classification Namefluid, intraocular
Generic Namesilicone oil
Regulation Number886.4275
ApplicantBAUSCH & LOMB, INC.
PMA NumberP910071
Supplement NumberS007
Date Received09/07/2005
Decision Date12/16/2005
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) change of the tip cap of the 10 ml hypac scf syringe from containing dry natural rubber material to latex-free material and 2) revision of the labeling to remove the "dry natural rubber" statement.
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