PERFLUORON

FDA Premarket Approval P950018 S019

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

Replacement of clean steam generator

DevicePERFLUORON
Generic NameFluid, Intraocular
ApplicantALCON LABORATORIES
Date Received2020-06-29
Decision Date2020-07-24
PMAP950018
SupplementS019
Product CodeLWL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ALCON LABORATORIES 6201 South Freeway R3-48 fort Worth, TX 76134

Supplemental Filings

Supplement NumberDateSupplement Type
P950018Original Filing
S019 2020-06-29 30-day Notice
S018 2015-03-26 30-day Notice
S017
S016 2012-11-08 Normal 180 Day Track
S015 2012-01-30 Real-time Process
S014 2010-11-22 30-day Notice
S013 2010-03-05 30-day Notice
S012
S011 2009-07-14 Normal 180 Day Track
S010 2008-04-15 Normal 180 Day Track No User Fee
S009 2003-02-14 Real-time Process
S008 2001-12-26 Real-time Process
S007 2001-07-13 30-day Notice
S006 2001-04-24 30-day Notice
S005 2001-02-26 30-day Notice
S004 2000-02-17 Normal 180 Day Track
S003 1999-03-26 Normal 180 Day Track
S002 1999-02-11 Real-time Process
S001 1996-10-17 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00380659001642 P950018 000
10380659001632 P950018 000
00380659001642 P950018 000
10380659001632 P950018 000

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