- Device
- Medtronic CoreValve™ EnVeo™ R Delivery Catheter System, Medtronic CoreValve™ EnVeo™ Pro Delivery Catheter System, Medtro
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S106
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-12-01
- Decision code
- OK30
- Date received
- 2021-11-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automation of an in-process inspection of the delivery catheter system.