|
Device | PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR |
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 | S010 |
Date Received | 02/19/2016 |
Decision Date | 03/09/2016 |
Product Code |
MDP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implementation of a new manufacturing site for the vendor [Neat Co., Ltd.] of the GD cap component of the Plasmaflo OP-05W(A) device. |