Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System
FDA premarket approval P130021/S097 · decided 2021-08-10
Approval details
- PMA number
- P130021
- Supplement
- S097
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Medtronic, Inc.
- Date received
- 2021-05-25
- Decision date
- 2021-08-10
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miinneapolis, MN
- Statement
- Approval for modifications to the Instructions for Use to reflect the 1-year findings of the Medtronic CoreValve Low Risk Bicuspid Post Approval Study.
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