PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)

Fluid, Intraocular

FDA Premarket Approval P950018

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for perfluoron (purified perfluoro-n-octane liquid) this device, a perfluorocarbon liquid, is an intraoperative tool

DevicePERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)
Classification NameFluid, Intraocular
Generic NameFluid, Intraocular
ApplicantALCON LABORATORIES
Date Received1995-04-28
Decision Date1996-02-29
Notice Date1996-07-18
PMAP950018
SupplementS
Product CodeLWL
Docket Number96M-0233
Advisory CommitteeOphthalmic
Expedited ReviewYes
Combination Product No
Applicant Address ALCON LABORATORIES 6201 South Freeway R3-48 fort Worth, TX 76134

Supplemental Filings

Supplement NumberDateSupplement Type
P950018Original Filing
S021 2022-07-18 30-day Notice
S020 2021-10-26 30-day Notice
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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.