- Device
- CoreValve™ Evolut™ R Delivery Catheter System, CoreValve™ Evolut™ Pro Delivery Catheter System, Evolut™ Pro+ Delivery Ca
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S108
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2022-02-09
- Decision code
- OK30
- Date received
- 2022-01-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative manufacturing site for a sub-tier supplier and addition of an antioxidant to the raw material used for a component of the delivery system.