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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 NameSILIKON 1000
Classification Namefluid, intraocular
Generic Namesilicone oil 1000cp
Regulation Number886.4275
ApplicantALCON
PMA NumberP950008
Supplement NumberS003
Date Received10/04/2001
Decision Date01/23/2002
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the molecular weight range specification for silikon 1000 from 36,000 - 48,000 dalton to 32,850 - 47,000 dalton.
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