PMA P130021S072
- Device
- Evolut R, Evolut PRO and Evolut PRO+ Systems
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S072
- Product code
- NPT
- Decision date
- 2020-05-28
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval for design changes to the actuator component of the delivery catheter system
Current openFDA PMA Record#
- Device
- Evolut R, Evolut PRO and Evolut PRO+ Systems
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S072
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2020-05-28
- Decision code
- APPR
- Date received
- 2020-03-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design changes to the actuator component of the delivery catheter system