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.
 
DeviceSURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantFerrosan Meidcal Devices A/S
Sydmarken 5
Soeborg 08876
PMA NumberP990004
Supplement NumberS025
Date Received10/24/2014
Decision Date05/16/2016
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for a packaging change to introduce a new packaging configuration for the Thrombin Kit Package for SURGIFLO Hemostatic Matrix Kit with Thrombin. This change was requested for the manufacturing site located at SteriPack Medical Poland SP. ZO.O., Poland, for the contract packaging of the SURGIFLO Hemostatic Matrix Device and the sterilizing site located at Synergy Health Ede BV, Netherlands, for the sterilization of the SURGIFLO Hemostatic Matrix Device.
-
-