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.
 
DeviceSTARCLOSE SE VASCULAR CLOSURE SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantABBOTT VASCULAR DEVICES
3200 LAKESIDE DRIVE
SANTA CLARA, CA 95054
PMA NumberP050007
Supplement NumberS027
Date Received10/05/2010
Decision Date01/07/2011
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MINOR DESIGN CHANGES TO THE VESSEL LOCATOR SPRING AND SPRING RETAINER COMPONENTS.
-
-