ISPAN PERFLUOROPROPANE C3F8

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Premarket Approval P900066 S008

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

Approval for change of perfluoropropane gas supplier.

DeviceISPAN PERFLUOROPROPANE C3F8
Classification NameGases Used Within Eye To Place Pressure On Detached Retina
Generic NameGases Used Within Eye To Place Pressure On Detached Retina
ApplicantAirgas USA, LLC
Date Received2008-07-21
Decision Date2009-02-19
PMAP900066
SupplementS008
Product CodeLPO
Advisory CommitteeOphthalmic
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Airgas USA, LLC 6141 Easton Road plumsteadville, PA 18949

Supplemental Filings

Supplement NumberDateSupplement Type
P900066Original Filing
S015 2022-01-06 30-day Notice
S014
S013 2021-08-31 30-day Notice
S012
S011 2011-12-06 30-day Notice
S010 2010-07-19 30-day Notice
S009 2009-08-13 Special (immediate Track)
S008 2008-07-21 135 Review Track For 30-day Notice
S007
S006 2002-08-13 135 Review Track For 30-day Notice
S005 2001-12-26 Special (immediate Track)
S004 2000-08-18 Special (immediate Track)
S003 1999-09-21 Normal 180 Day Track
S002 1996-08-23 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
00380657971039 P900066 000
00380657971022 P900066 000
00380657971015 P900066 000
00380657971053 P900066 002
00380657971046 P900066 002

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