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,ILIAC,VENOUS) ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS
Classification Nameshunt, portosystemic, endoprosthesis
Generic Namestent endoprosthesis
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP930031
Supplement NumberS011
Date Received12/20/2001
Decision Date01/10/2002
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing facility located at boston scientific ireland ltd. (bsil), galway, ireland and an alternate sterilization facility located at isotron, offaly, ireland.
-
-