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
 
DeviceSAPIEN M3 Transcatheter Mitral Valve Replacement System
Generic NameProsthesis, mitral valve, percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP250019
Date Received06/25/2025
Decision Date12/22/2025
Product Code NPU 
Docket Number FDA-7398
Notice Date 12/30/2025
Advisory Committee Cardiovascular
Clinical TrialsNCT04153292
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the SAPIEN M3 transcatheter mitral valve replacement system. This device is indicated for the treatment of symptomatic moderate-to-severe or severe mitral regurgitation (MR) in patients who are deemed unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy by a multidisciplinary heart team. It is also indicated for the treatment of symptomatic mitral valve dysfunction (moderate-to-severe or severe MR, severe mitral stenosis (MS), or moderate MR with moderate MS) associated with mitral annular calcification (MAC) in patients who are deemed unsuitable for surgery or TEER therapy by a multidisciplinary heart team.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
-
-