PMA P200046S006
- Device
- Harmony Transcatheter Pulmonary Valve
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S006
- Product code
- NPV
- Decision date
- 2021-12-16
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- Establishment of an in-process shelf life for fixed tissue placed in storage.
Current openFDA PMA Record#
- Device
- Harmony Transcatheter Pulmonary Valve
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S006
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2021-12-16
- Decision code
- OK30
- Date received
- 2021-12-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Establishment of an in-process shelf life for fixed tissue placed in storage.