PMA P140017S023
- Device
- Medtronic Melody Transcatheter Pulmonic Valve System
- Applicant
- Medtronic, Inc.
- PMA number
- P140017
- Supplement
- S023
- Product code
- NPV
- Decision date
- 2022-11-28
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- Modifications to the tissue inspection process at tissue processing and valve assembly manufacturing steps.
Current openFDA PMA Record#
- Device
- Medtronic Melody Transcatheter Pulmonic Valve System
- Applicant
- Medtronic, Inc.
- PMA number
- P140017
- Supplement
- S023
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2022-11-28
- Decision code
- OK30
- Date received
- 2022-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the tissue inspection process at tissue processing and valve assembly manufacturing steps.