PMA P130021S100
- Device
- Evolut PRO+ Delivery Catheter System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S100
- Product code
- NPT
- Decision date
- 2021-07-12
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Dimensional modifications to a measurement tool used for in-process inspection of the delivery catheter.
Current openFDA PMA Record#
- Device
- Evolut PRO+ Delivery Catheter System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S100
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-07-12
- Decision code
- OK30
- Date received
- 2021-07-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Dimensional modifications to a measurement tool used for in-process inspection of the delivery catheter.