- Device
- Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System, Medtronic Evol
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S109
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2022-04-29
- Decision code
- APPR
- Date received
- 2022-01-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for 1) modifications to the Medtronic Evolut FX Instructions for Use to include the clinical data; and 2) reformatting the clinical study summaries and revising the legal manufacturer address in the IFUs for the Evolut R, Evolut PRO, Evolut PRO+, and Evolut FX Systems.