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.
 
DeviceACTIFOAM ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantColetica S.A.
32 Rue St., Jean De Dieu
Lyon 69007
PMA NumberP930030
Supplement NumberS001
Date Received11/02/1995
Decision Date11/30/1995
Withdrawal Date01/23/2017
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN TRADE NAME THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME ACTIFOAM ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
-
-