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 NumberS005
Date Received08/18/2009
Decision Date03/16/2010
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE PLASMAFLO OP-05W(A). THE DEVICE, IS INTENDED AS A REPLACEMENT FOR THE PLASMAFLO AP-05H AND THE PLASMAFLO AP-05H(L). THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME PLASMAFLO OP-05W(A) AND IS INDICATED FOR USE IN THERAPEUTIC PROCEDURES REQUIRING SEPARATION OF PLASMA FROM WHOLE BLOOD.
-
-