SILIKON 1000

Fluid, Intraocular

FDA Premarket Approval P950008 S007

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.

Pre-market Approval Supplement Details

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.

DeviceSILIKON 1000
Classification NameFluid, Intraocular
Generic NameFluid, Intraocular
ApplicantALCON
Date Received2009-05-04
Decision Date2009-10-30
PMAP950008
SupplementS007
Product CodeLWL
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ALCON 6201 South Freeway mail Drop R7-14 fort Worth, TX 76134-2099

Supplemental Filings

Supplement NumberDateSupplement Type
P950008Original Filing
S015 2021-01-19 30-day Notice
S014 2018-05-08 Special (immediate Track)
S013 2016-06-24 30-day Notice
S012 2014-07-07 Normal 180 Day Track No User Fee
S011 2013-10-22 30-day Notice
S010 2013-06-11 Special (immediate Track)
S009 2013-04-10 30-day Notice
S008 2011-02-11 30-day Notice
S007 2009-05-04 Real-time Process
S006 2003-12-15 Real-time Process
S005
S004 2001-12-06 30-day Notice
S003 2001-10-04 Normal 180 Day Track
S002 2001-01-22 Real-time Process
S001 2000-06-19 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00380656011859 P950008 000
00380656011873 P950008 012

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