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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
 
DeviceISPAN SULFUR HEXAFLUORIDE SF6 GAS
Classification Namegases used within eye to place pressure on detached retina
Generic Namegases used within eye to place pressure on detached retina
Regulation Number886.4270
Applicant
Airgas USA, LLC
6141 easton road
plumsteadville, PA 18949
PMA NumberP900067
Supplement NumberS007
Date Received12/22/2011
Decision Date01/20/2012
Product Code
LPO[ Registered Establishments with LPO ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
REPLACE THE ION CHROMATOGRAPH FOR QUALITY CONTROL PRODUCT TESTING.
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