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. |
|
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 | S008 |
Date Received | 10/12/2011 |
Decision Date | 11/02/2011 |
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 MOVING THE PLASMAFLO MANUFACTURING EQUIPMENT TO A NEW FACILITY LOCATED WITHIN THE CURRENT MANUFACTURING SITE. |
|
|