Medtronic Corevalve System
FDA premarket approval P130021 · Aortic valve, prosthesis, percutaneously delivered
PMA numberP130021
Approval
- Applicant
- Medtronic, Inc.
- Received
- July 22, 2013
- Decision date
- January 17, 2014 (APPR)
- Supplements
- 182, latest August 10, 2026
- Product code
- NPT – Aortic Valve, Prosthesis, Percutaneously Delivered
Approval order statement
Approval for the Medtronic CoreValve System. This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ? 0.8 cm2, a mean aortic valve gradient of > 40 mmHg, or a peak aortic-jet velocity of > 4.0 m/s) and with native aortic annulus diameters between 18 and 29 mm who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy (predicted risk of operative mortality and/or serious irreversible morbidity ? 50% at 30 days).