PMA P130021S089
- Device
- Evolut PRO+ System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S089
- Product code
- NPT
- Decision date
- 2021-03-24
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Introduction of an additional pre-heating workstep to the manufacturing of the 18Fr delivery system.
Current openFDA PMA Record#
- Device
- Evolut PRO+ System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S089
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-03-24
- Decision code
- OK30
- Date received
- 2021-03-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of an additional pre-heating workstep to the manufacturing of the 18Fr delivery system.