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. |
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Device | COBE CENTRY(R) TPE SYSTEM |
Generic Name | Separator, automated, blood cell and plasma, therapeutic |
Applicant | GAMBRO BCT, INC. 10811 West Collins Ave. Lakewood, CO 80215 |
PMA Number | P810023 |
Supplement Number | S002 |
Date Received | 04/19/1993 |
Decision Date | 07/05/1994 |
Withdrawal Date
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10/09/2007 |
Product Code |
LKN |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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