PMA P130021S066
- Device
- CoreValve Evolut R and Evolut PRO Systems
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S066
- Product code
- NPT
- Decision date
- 2019-10-29
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Addition of new equipment for the manufacturing of delivery catheter system sub-assemblies.
Current openFDA PMA Record#
- Device
- CoreValve Evolut R and Evolut PRO Systems
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S066
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-10-29
- Decision code
- OK30
- Date received
- 2019-10-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of new equipment for the manufacturing of delivery catheter system sub-assemblies.