PMA P130021S129
- Device
- Medtronic CoreValve Evolut FX System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S129
- Product code
- NPT
- Decision date
- 2022-12-01
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Modifications to final inspection test equipment and methods to evaluate torque and tensile force performance.
Current openFDA PMA Record#
- Device
- Medtronic CoreValve Evolut FX System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S129
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2022-12-01
- Decision code
- OK30
- Date received
- 2022-11-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to final inspection test equipment and methods to evaluate torque and tensile force performance.