• 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 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.
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
400 saginaw drive
redwood city, CA 94063
PMA NumberP960043
Supplement NumberS080
Date Received07/20/2012
Decision Date04/15/2013
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 13M-0464
Notice Date 05/07/2013
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the perclose® proglide¿ suture mediated closure system. This device is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patientswho have undergone diagnostic or interventional catheterization procedures using 5f to 21 f sheaths; for sheath sizes greater than 8f, at least two devices and the pre-close technique arerequired.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling