PMA P130021S084
- Device
- Evolut PRO+ TAV of the Evolut PRO+ System, Evolut PRO TAV of the Evolut PRO System and Evolut R TAV of the Evolut R Syst
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S084
- Product code
- NPT
- Decision date
- 2021-01-06
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Addition of a new cleanroom.
Current openFDA PMA Record#
- Device
- Evolut PRO+ TAV of the Evolut PRO+ System, Evolut PRO TAV of the Evolut PRO System and Evolut R TAV of the Evolut R Syst
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S084
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-01-06
- Decision code
- OK30
- Date received
- 2021-01-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new cleanroom.