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.
 
DeviceDUETT PRO SEALING DEVICE MODEL 1010
Generic NameDevice, hemostasis, vascular
ApplicantVascular Solutions, Inc.
6464 SYCAMORE COURT NORTH
MINNEAPOLIS, MN 55369
PMA NumberP990037
Supplement NumberS022
Date Received06/15/2004
Decision Date07/09/2004
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIS CORP., ISOMEDIX SERVICES, MINNEAPOLIS, MINNESOTA.
-
-