Silikon 1000

FDA Premarket Approval P950008 S015

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

The implementation of an alternate indicator for demonstrating successful terminal sterilization for silikon 1000

DeviceSilikon 1000
Generic NameFluid, Intraocular
ApplicantALCON
Date Received2021-01-19
Decision Date2021-02-15
PMAP950008
SupplementS015
Product CodeLWL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
00380656011859 P950008 000
00380656011873 P950008 012
00380656011873 P950008 012

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