PMA P140017S020
- Device
- Melody Transcatheter Pulmonary Valve
- Applicant
- Medtronic, Inc.
- PMA number
- P140017
- Supplement
- S020
- Product code
- NPV
- Decision date
- 2022-02-02
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- New cleanroom area for various manufacturing processes at an existing site.
Current openFDA PMA Record#
- Device
- Melody Transcatheter Pulmonary Valve
- Applicant
- Medtronic, Inc.
- PMA number
- P140017
- Supplement
- S020
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2022-02-02
- Decision code
- OK30
- Date received
- 2022-01-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New cleanroom area for various manufacturing processes at an existing site.