PMA P130021S080
- Device
- CoreValve Evolut R and Evolut PRO System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S080
- Product code
- NPT
- Decision date
- 2020-10-05
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval for a site change for packaging and labeling rework processes.
Current openFDA PMA Record#
- Device
- CoreValve Evolut R and Evolut PRO System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S080
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2020-10-05
- Decision code
- APPR
- Date received
- 2020-07-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a site change for packaging and labeling rework processes.