• 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.
 
DeviceX-PRESS TRIMMER - ACCESSORY TO THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
St. Jude Medical, Inc.
6500 wedgwood rd.
maple grove, MN 55311
PMA NumberP020035
Supplement NumberS001
Date Received11/04/2003
Decision Date12/18/2003
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 A NEW ACCESSORY THAT INCORPORATES THE KNOT PUSHER AND SUTURE CUTTER ACCESSORIES INTO A SINGLE DEVICE. THIS NEWLY CREATED ACCESSORY WILL BE MARKETED UNDER THE TRADE NAME X-PRESS TRIMMER, WHICH ALLOWS THE OPERATOR TO PUSH THE CLINCH KNOT AND CUT THE SUTURE BELOW THE SKIN LINE FOLLOWING THE USE OF THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM.
-
-