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 | 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 | S006 |
Date Received | 07/07/2010 |
Decision Date | 08/06/2010 |
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 ADDITION OF A SECOND PROCESS EQUIPMENT SET-UP FOR CERTAIN PROCESS STEPS IN THE MANUFACTURING OF THE FINISHED DEVICE AND REPLACEMENT OF A MOLD. |
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