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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.
 
DevicePERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
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 NumberS003
Date Received09/21/1999
Decision Date03/16/2000
Product Code LPO 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
1)Change in manufacturing site; 2)Alternate synthesis route for perfluoropropane; and 3) Changing release specification for the perfluoropropane gas.
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