ISPAN SULFUR HEXAFLUORIDE SF6 GAS

FDA Premarket Approval P900067 S005

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

Change of sulfur hexafluoride gas supplier.

DeviceISPAN SULFUR HEXAFLUORIDE SF6 GAS
Generic NameGases Used Within Eye To Place Pressure On Detached Retina
ApplicantAirgas USA, LLC
Date Received2008-11-09
Decision Date2008-12-09
PMAP900067
SupplementS005
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
P900067Original Filing
S007 2011-12-22 30-day Notice
S006 2009-08-13 Special (immediate Track)
S005 2008-11-09 30-day Notice
S004
S003 2001-12-26 Special (immediate Track)
S002 1996-08-23 Normal 180 Day Track
S001

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