- Device
- Structural Heart Delivery Catheter Systems & Loading systems
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S092
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-05-21
- Decision code
- APPR
- Date received
- 2021-04-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for additional verification of the date of manufacture and use by date for devices undergoing rework activities.