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 NameWALLSTENT (TIPS AND VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Classification Nameshunt, portosystemic, endoprosthesis
Generic Nameendoprosthesis with unistep plus delivery system
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP930031
Supplement NumberS022
Date Received06/25/2004
Decision Date07/22/2004
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Reduction in bond cure times for two processing steps used in the manufacture of the stent delivery catheter for the above-stated devices.
-
-