PMA P130021S058
- Device
- Medtronic CoreValve™ Evolut™ R System and Medtronic CoreValve™ Evolut™ Pro System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S058
- Product code
- NPT
- Decision date
- 2019-08-16
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval for the Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System for expanding the indication to include patients at low risk for surgical aortic valve replacement. The devices are 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 appropriate for the transcatheter heart valve replacement therapy.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130021S058B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- Medtronic CoreValve™ Evolut™ R System and Medtronic CoreValve™ Evolut™ Pro System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S058
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-08-16
- Decision code
- APPR
- Date received
- 2019-03-15
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System for expanding the indication to include patients at low risk for surgical aortic valve replacement. The devices are 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 appropriate for the transcatheter heart valve replacement therapy.