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.
 
DeviceMedtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System, Medtronic Evol
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantMedtronic, Inc.
710 Medtronic Pkwy.
Miinneapolis, MN 55432
PMA NumberP130021
Supplement NumberS109
Date Received01/28/2022
Decision Date04/29/2022
Product Code NPT 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for 1) modifications to the Medtronic Evolut FX Instructions for Use to include the clinical data; and 2) reformatting the clinical study summaries and revising the legal manufacturer address in the IFUs for the Evolut R, Evolut PRO, Evolut PRO+, and Evolut FX Systems.
-
-