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.
 
DeviceINSTAT COLLAGEN HEMOSTAT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE, NJ 08876-0151
PMA NumberP830079
Supplement NumberS016
Date Received06/24/2005
Decision Date07/22/2005
Withdrawal Date 10/18/2021
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, WHIPPANY, NEW JERSEY.
-
-