- Device
- CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S128
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2022-12-01
- Decision code
- OK30
- Date received
- 2022-11-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement an alternative bacterial water testing method.