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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSILIKON 1000
Classification Namefluid, intraocular
Generic Namefluid, intraocular
Regulation Number886.4275
Applicant
ALCON
6201 south freeway
mail drop r7-14
fort worth, TX 76134-2099
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/material
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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