PMA P130021S131
- Device
- Evolut FX Delivery Catheter System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S131
- Product code
- NPT
- Decision date
- 2023-01-29
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- New sub-tier supplier for a component of the Evolut FX delivery catheter system.
Current openFDA PMA Record#
- Device
- Evolut FX Delivery Catheter System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S131
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2023-01-29
- Decision code
- OK30
- Date received
- 2023-01-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New sub-tier supplier for a component of the Evolut FX delivery catheter system.