• 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePROSORBA(TM) COLUMN
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nameseparator, automated, blood cell and plasma, therapeutic
ApplicantFRESENIUS HEMOCARE, INC.
PMA NumberP850020
Supplement NumberS008
Date Received08/12/1994
Decision Date09/27/1996
Product Code
LKN[ Registered Establishments with LKN ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the package insert (i. E. , revisions to the sections entitled column preparation, off-line procedure and on-line procedure, including more detailed instructions for use, illustrations of the device set-up, increased patient monitoring and refinement of specified plasma flow rates) and a procedure change involving the use of an "in-line" leukocyte removal filtr for microaggregate removal which is to be inserted in te blood line returning treated plasma to the patient.
-
-