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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 PERFLUOROPROPANE C3F8
Generic NameGases used within eye to place pressure on detached retina
Regulation Number886.4270
ApplicantAirgas Therapeutics, LLC
6141 Easton Rd.
Plumsteadville, PA 18949
PMA NumberP900066
Supplement NumberS008
Date Received07/21/2008
Decision Date02/19/2009
Product Code LPO 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGE OF PERFLUOROPROPANE GAS SUPPLIER.
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