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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 Road
Plumsteadville, PA 18949
PMA NumberP900066
Supplement NumberS004
Date Received08/18/2000
Decision Date09/05/2000
Product Code LPO 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE TOXICITY TEST PROTOCOL TO INCREASE THE NUMBER OF SAMPLES TO BE TESTED FROM EACH PRODUCTION LOT OF PERFLUOROPROPANE FROM ONE SAMPLE PER LOT TO THREE SAMPLES PER LOT.
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