PMA P130021S061
- Device
- CoreValve Evolut R System and CoreValve Evolut PRO System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S061
- Product code
- NPT
- Decision date
- 2019-08-19
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Modification to the nitinol capsule frame used in the 18F and 20F delivery systems.
Current openFDA PMA Record#
- Device
- CoreValve Evolut R System and CoreValve Evolut PRO System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S061
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-08-19
- Decision code
- OK30
- Date received
- 2019-08-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the nitinol capsule frame used in the 18F and 20F delivery systems.