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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.
 
DeviceCURESIS PLASMA SEPARATOR
Generic NameSeparator for therapeutic purposes, membrane automated blood cell/plasma
ApplicantORGANON TEKNIKA CORP.
5300 SOUTH PORTLAND AVE.
OKLAHOMA CITY, OK 73119
PMA NumberP830010
Supplement NumberS003
Date Received07/30/1985
Decision Date12/06/1985
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
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