• 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 | Inspections
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 NameSTARCLOSE SE VASCULAR CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namevascular closure system
ApplicantABBOTT VASCULAR DEVICES
PMA NumberP050007
Supplement NumberS004
Date Received10/24/2006
Decision Date03/23/2007
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design changes t the starclose vascular closure system (vcs). The device, as modified, will be marketed under the trade name starclose se vascular closure system and is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis and ambulation, in patients who have undergone diagnostic or interventional endovascular catheterization procedures utilizing a 5f or 6f procedural sheath and for the percutaneous closure of common femoral artery access sites while reducing time to dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5f or 6f procedural sheath.
-
-