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 AND DIAGNOSTIC DUETT PRO SEALING DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantVascular Solutions, Inc.
6464 Sycamore Ct. N.
Minneapolis, MN 55369
PMA NumberP990037
Supplement NumberS021
Date Received06/15/2004
Decision Date07/14/2004
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFYING THE PRESSURE RELIEF VALVE COMPONENT ON THE CATHETER AND REPLACING THE MIXING 20 GAUGE NEEDLE SYRINGE WITH A NEEDLELESS NON-CORING VIAL ACCESS DEVICE.
-
-