PMA P130021S063
- Device
- EnVeo R and PRO Delivery Catheter System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S063
- Product code
- NPT
- Decision date
- 2019-09-11
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Introduce a 100% torque test during actuator assembly for the EnVeo R and EnVeo PRO Delivery Catheter System (DCS).
Current openFDA PMA Record#
- Device
- EnVeo R and PRO Delivery Catheter System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S063
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-09-11
- Decision code
- OK30
- Date received
- 2019-09-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce a 100% torque test during actuator assembly for the EnVeo R and EnVeo PRO Delivery Catheter System (DCS).