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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.
 
DeviceCOBE CENTRY(R) TPE SYSTEM
Generic NameSeparator, automated, blood cell and plasma, therapeutic
ApplicantGambro Bct, Inc.
10811 W. Collins Ave.
Lakewood, CO 80215
PMA NumberP810023
Supplement NumberS002
Date Received04/19/1993
Decision Date07/05/1994
Withdrawal Date10/09/2007
Product Code LKN 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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