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.
 
DeviceProVee System for BPH
Generic NameSTENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
ApplicantProverum, Ltd.
2nd Floor Astor Hall, 4-8 Eden Quay
Dublin D01N5W8
PMA NumberP250011
Supplement NumberS004
Date Received06/04/2026
Decision Date07/01/2026
Product Code MER 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
To update the steering sheath component vertical heat shrinker reflow manufacturing procedure with the sheath supplier, and reduce the occurrence rate of bubble/void reflow defects in the steering sheath
-
-