PMA P130021S055
- Device
- CoreValve Evolut R, PRO Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S055
- Product code
- NPT
- Decision date
- 2018-11-09
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Modification to the leaflet thickness mapping process and the leaflet and skirts mapping templates for the Evolut R and Evolut PRO Transcatheter Aortic Valves.
Current openFDA PMA Record#
- Device
- CoreValve Evolut R, PRO Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S055
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2018-11-09
- Decision code
- OK30
- Date received
- 2018-10-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the leaflet thickness mapping process and the leaflet and skirts mapping templates for the Evolut R and Evolut PRO Transcatheter Aortic Valves.