ISPAN PERFLUOROPROPANE C3F8 GAS

FDA Premarket Approval P900066 S013

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

Use an additional supplier for toxicity testing as a product release test for perfluoropropane.

DeviceISPAN PERFLUOROPROPANE C3F8 GAS
Generic NameGases Used Within Eye To Place Pressure On Detached Retina
ApplicantAirgas USA, LLC
Date Received2021-08-31
Decision Date2021-09-28
PMAP900066
SupplementS013
Product CodeLPO 
Advisory CommitteeOphthalmic
Supplement Type30-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
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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