• 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 MATRIX HEMOSTATIC AGENT FLOSEAL ENDOSCOPIC APPLICATOR
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
Applicant
BAXTER HEALTHCARE CORP.
32650 n wilson rd
round lake, IL 60073
PMA NumberP990009
Supplement NumberS016
Date Received11/15/2004
Decision Date03/31/2005
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Recalls CDRH Recalls
Approval Order Statement 
APPROVAL FOR A MODIFICATION TO THE ENDOSCOPIC APPLICATOR AND A MODIFICATION OF THE "INDICATION FOR USE" FOR THE ENDOSCOPIC APPLICATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLOSEAL ENDOSCOPIC APPLICATOR AND IS INDICATED FOR USE IN DELIVERING FLOSEAL MATRIX HEMOSTATIC SEALANT TO BLEEDING SURGICAL SITES THROUGH A 5 MM OR LARGER TROCAR.
-
-