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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSILIKON 1000
Classification Namefluid, intraocular
Generic Namesilicone oil 1000cp
Regulation Number886.4275
ApplicantALCON
PMA NumberP950008
Date Received02/22/1995
Decision Date09/25/1997
Product Code
LWL[ Registered Establishments with LWL ]
Docket Number 97M-0521
Advisory Committee Ophthalmic
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the silikon 1000. This device is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (pvr), proliferative diabetic retinopathy (pdr), cytomegalovirus (cmv) retinitis, giant tears, and following perofrating injuries. Silikon 1000 is also indicated for primary use in detachments due to aids) related cmv retinitis and other viral infections affecting the retina.
Supplements: S001 S002 S003 S004 S006 S007 S008 S009 S010 
S011 
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