SILIKON 1000

Fluid, Intraocular

FDA Premarket Approval P950008 S004

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

Modification of testing methodology for low molecular weight siloxanes determination in silikon 1000.

• Device: SILIKON 1000
• Classification Name: Fluid, Intraocular
• Generic Name: Fluid, Intraocular
• Applicant: ALCON
• Date Received: 2001-12-06
• Decision Date: 2002-01-03
• PMA: P950008
• Supplement: S004
• Product Code: LWL
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day Notice
• Expedited Review: No
• Combination Product: No
• Applicant Address: ALCON 6201 South Freeway mail Drop R7-14 fort Worth, TX 76134-2099

Supplemental Filings

Supplement Number	Date	Supplement Type
P950008		Original 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 ID	PMA	Supp
00380656011859	P950008	000
00380656011873	P950008	012