• 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.
 
DeviceMELODY TRANSCATHETER PULMONARY VALVE , ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)
Generic Namepulmonary valve prosthesis percutaneously delivered
ApplicantMEDTRONIC Inc.
8200 coral sea street ne
mvs83
mounds view, MN 55112
PMA NumberP140017
Supplement NumberS006
Date Received11/23/2016
Decision Date05/22/2017
Product Code NPV 
Advisory Committee Cardiovascular
Clinical TrialsNCT00740870
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for updates to the Melody Transcatheter Pulmonary Valve System Instructions for Use to reflect the final results of the Long-Term Follow-up Post-Approval Study.
-
-