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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-OIL 5000 SILICONE OIL
Classification Namefluid, intraocular
Generic Namesilicone oil
Regulation Number886.4275
ApplicantBAUSCH & LOMB, INC.
PMA NumberP910071
Supplement NumberS005
Date Received06/05/2000
Decision Date03/22/2001
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes: 1) change of manufacturing site to pharm pur gmbh, augsburg, germany 2) specification revisions: a) change to the follwoing specifications: viscosity; resistivity; and contend of oligosiloxanes; and b) addition of the following specifications and their test methods; content of catalyst; heavy metals; endotoxins; acid content; cytotoxidity and acetone 3) change in the following method: determination of content of oh-end groups (changed from hnmr to karl fisher titration).
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