PMA P130021S073
- Device
- Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S073
- Product code
- NPT
- Decision date
- 2020-03-20
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval for the revised protocols for the post-approval studies protocol.
Current openFDA PMA Record#
- Device
- Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S073
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2020-03-20
- Decision code
- APPR
- Date received
- 2020-03-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the revised protocols for the post-approval studies protocol.