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.
 
DeviceSURGIFOAM Absorabable Gelatin Sponge, U.S.P., SURGIFLO Hemostatic Matrix, SURGIFLO Hemostatic MatrixKit with Thrombin
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantFerrosan Meidcal Devices A/S
Sydmarken 5
Soeborg 08876
PMA NumberP990004
Supplement NumberS055
Date Received06/27/2022
Decision Date12/21/2022
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an additional sterilization chamber to be used for Gamma irradiation at the current Gamma sterilization site
-
-