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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 5000
Classification Namefluid, intraocular
Generic Namesilicone oil
Regulation Number886.4275
ApplicantBAUSCH & LOMB, INC.
PMA NumberP910071
Supplement NumberS004
Date Received07/08/1997
Decision Date12/24/1997
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Requested that a phase iv trial of adatosil 5000(tm) no longer be required as a condition of approval for this pma, and that the current labeling be revised to state more specificaly the role of the physician in determining the use and removal of adatosil 5000(tm) silicone oil.
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