Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System
FDA premarket approval P130021/S058 · decided 2019-08-16
Approval details
- PMA number
- P130021
- Supplement
- S058
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Medtronic, Inc.
- Date received
- 2019-03-15
- Decision date
- 2019-08-16
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miinneapolis, MN
- 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.
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