PMA P130021S101
- Device
- Medtronic CoreValve Evolut PRO System, Medtronic CoreValve Evolut PRO+ System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S101
- Product code
- NPT
- Decision date
- 2021-07-19
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Addition of a new tissue supplier.
Current openFDA PMA Record#
- Device
- Medtronic CoreValve Evolut PRO System, Medtronic CoreValve Evolut PRO+ System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S101
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-07-19
- Decision code
- OK30
- Date received
- 2021-07-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new tissue supplier.