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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDUETT SEALING DEVICE
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantVASCULAR SOLUTIONS, INC.
PMA NumberP990037
Supplement NumberS013
Date Received01/23/2003
Decision Date02/21/2003
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the manufacturing procedures to propose reduction in pouch and seal strength tolerance, tolerance change to the knob base and hub base, changes to the sealing achange in the manufacturing procedures to propose reduction in pouch and seal strength tolerance, tolerance change to the knob base and hub base, changes to the sealing and pilot balloons, sleeve marking changes and reduction in the bioburden monitoring limits for the duett family of sealing devices. Nd pilot balloons, sleeve marking changes and reduction in the bioburden monitoring limits for the duett family of sealing devices.
-
-