Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DevicePlasmaflo OP-05W(A)
Generic NameSeparator for therapeutic purposes, membrane automated blood cell/plasma
ApplicantAsahi Kasei Medical Co., Ltd.
1-105 Kanda Jinbocho
Chiyoda-Ku
Tokyo 101-8101
PMA NumberP820033
Supplement NumberS017
Date Received02/06/2024
Decision Date09/30/2025
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Your supplement requested approval for a change in the supplier of the lubricant, calcium stearate, added to the polyethylene resin used in the manufacture of the hollow fiber of the device.
-
-