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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
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantAlcon
6201 S. Fwy.
Mail Drop R7-14
Fort Worth, TX 76134
PMA NumberP950008
Supplement NumberS007
Date Received05/04/2009
Decision Date10/30/2009
Product Code LWL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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