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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 NumberS007
Date Received05/04/2009
Decision Date10/30/2009
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications of specification ranges for viscosity and molecular weight. The current specifications for viscosity and molecular weight are 900 ¿ 1,250 cs and 32,850 ¿ 47,000 daltons, respectively. The proposed regulatory acceptance specifications for viscosity and molecular weight are 980 ¿ 1,350 cs and 31,000 ¿ 44,500 daltons, respectively.
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