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Device | PLASMAFLO OP-05W (A) |
Generic Name | Separator for therapeutic purposes, membrane automated blood cell/plasma |
Applicant | Asahi Kasei Medical Co., Ltd. 1-105 KANDA JINBOCHO CHIYODA-KU TOKYO 101-8-8101 |
PMA Number | P820033 |
Supplement Number | S005 |
Date Received | 08/18/2009 |
Decision Date | 03/16/2010 |
Product Code |
MDP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE PLASMAFLO OP-05W(A). THE DEVICE, IS INTENDED AS A REPLACEMENT FOR THE PLASMAFLO AP-05H AND THE PLASMAFLO AP-05H(L). THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME PLASMAFLO OP-05W(A) AND IS INDICATED FOR USE IN THERAPEUTIC PROCEDURES REQUIRING SEPARATION OF PLASMA FROM WHOLE BLOOD. |