• 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 | Inspections

New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameaortic valve, prosthesis, percutaneously delivered
PMA NumberP140031
Date Received12/22/2014
Decision Date06/17/2015
Product Code
NPT[ Registered Establishments with NPT ]
Docket Number 15M-2499
Notice Date 07/16/2015
Advisory Committee Cardiovascular
Clinical Trials NCT01314313
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories. This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i. E. , society of thoracic surgeons operative risk score 8% or at a 15% risk of mortality at 30 days).
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001