PMA P130021S105
- Device
- Medtronic Evolut™ Pro+ Transcatheter Delivery Catheter System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S105
- Product code
- NPT
- Decision date
- 2021-10-19
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Additional visual inspection for the delivery catheter system sub-assembly component.
Current openFDA PMA Record#
- Device
- Medtronic Evolut™ Pro+ Transcatheter Delivery Catheter System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S105
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-10-19
- Decision code
- OK30
- Date received
- 2021-10-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional visual inspection for the delivery catheter system sub-assembly component.