PMA P130021S178
- Device
- Medtronic Evolut™ PRO+ Delivery Catheter System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S178
- Product code
- NPT
- Decision date
- 2025-10-22
- Classification
- Cardiovascular
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- implementation of an alternative semi-automated threading and measurement system
Current openFDA PMA Record#
- Device
- Medtronic Evolut™ PRO+ Delivery Catheter System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S178
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2025-10-22
- Decision code
- OK30
- Date received
- 2025-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of an alternative semi-automated threading and measurement system