PMA P140017S031
- Device
- Melody Transcatheter Pumonary Valve System
- Applicant
- Medtronic, Inc.
- PMA number
- P140017
- Supplement
- S031
- Product code
- NPV
- Decision date
- 2025-08-21
- Classification
- Cardiovascular
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- an increase in the maximum occupancy level in the Main Room and Gown Room of controlled environment area (CEA) 5
Current openFDA PMA Record#
- Device
- Melody Transcatheter Pumonary Valve System
- Applicant
- Medtronic, Inc.
- PMA number
- P140017
- Supplement
- S031
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2025-08-21
- Decision code
- OK30
- Date received
- 2025-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an increase in the maximum occupancy level in the Main Room and Gown Room of controlled environment area (CEA) 5