=99.9% FOR PURIFIED PERFLUORO-N-OCTANE REMAINS UNCHANGED.">

PERFLUORON

FDA Premarket Approval P950018 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

Elimination of finished product intravitreal testing for perfluoron and revision of the "purified perfluoro-n-octane analytical test monograph" regarding calculation of impurities. The specification of >=99. 9% for purified perfluoro-n-octane remains unchanged.

DevicePERFLUORON
Generic NameFluid, Intraocular
ApplicantALCON LABORATORIES
Date Received2001-07-13
Decision Date2001-08-07
PMAP950018
SupplementS007
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
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

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