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.
 
DeviceFloseal Hemostatic Matrix
Generic NameAbsorbable collagen hemostatic agent with thrombin
Regulation Number878.4490
ApplicantBaxter Healthcare Corp
32650 N. Wilson Rd.
Round Lake, IL 60073
PMA NumberP990009
Supplement NumberS067
Date Received09/30/2021
Decision Date03/09/2022
Product Code PMX 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for kitting an alternate 5 mL FLOSEAL kit configuration, where the human Thrombin vial will be replaced with a vial of recombinant human Thrombin (RECOTHROM).
-
-