PMA P130021S060
- Device
- CoreValve Evolut R and CoreValve Evolut PRO transcatheter aortic valves (TAV)
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S060
- Product code
- NPT
- Decision date
- 2019-07-02
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Addition of a new sewing aid for final valve assembly of Evolut R and Evolut PRO Transcatheter Aortic Valves.
Current openFDA PMA Record#
- Device
- CoreValve Evolut R and CoreValve Evolut PRO transcatheter aortic valves (TAV)
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S060
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-07-02
- Decision code
- OK30
- Date received
- 2019-06-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new sewing aid for final valve assembly of Evolut R and Evolut PRO Transcatheter Aortic Valves.