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.
 
DeviceUROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS
Generic NameSTENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP920023
Supplement NumberS003
Date Received04/25/1997
Decision Date04/29/1997
Withdrawal Date04/11/2016
Product Code MER 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE POST-APPROVAL STUDIES.
-
-