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.
 
DeviceENSEMBLE II TRANSCATHETER VALVE DELIVERY SYSTEM
Generic NamePulmonary valve prosthesis percutaneously delivered
ApplicantMedtronic, Inc.
8200 Coral Sea St. NE Mvs83
Mounds View, MN 55112
PMA NumberP140017
Supplement NumberS004
Date Received04/25/2016
Decision Date09/12/2016
Product Code NPV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a product line extension to the Ensemble Transcatheter Valve Delivery System.
-
-