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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.
 
DevicePLASMA SEPARATION SYSTEM
Generic NameSeparator, automated, blood cell and plasma, therapeutic
ApplicantFenwal, Inc.
Three Corporate Dr.
Lake Zurich, IL 60047
PMA NumberP820032
Supplement NumberS005
Date Received07/07/1987
Decision Date08/25/1987
Withdrawal Date07/10/2014
Product Code LKN 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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