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.
 
DeviceCOSTASIS/DYNASTAT SURGICAL HEMOSTAT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantAngiotech Medical Device Technologies
3600 S.W 47th Ave.
Gainesville, FL 32608
PMA NumberP990030
Supplement NumberS002
Date Received11/20/2001
Decision Date12/21/2001
Withdrawal Date03/07/2012
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate 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 MODIFICATIONS TO THE COSTASIS(R)/DYNASTAT(TM) SURGICAL HEMOSTATS' PRODUCT LABELING.
-
-