|
Device | PLASMAFLO |
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 | S009 |
Date Received | 11/06/2015 |
Decision Date | 12/03/2015 |
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 ADD A NEW VENDOR FOR THE BROMINATED POLYCARBONATE RAW MATERIAL IN THE MANUFACTURE OF THE COMPONENTS OF THE PLASMAFLOTM OP-05 W (A) ASAHI PLASMA SEPARATOR. |