PMA P200046S002
- Device
- Harmony Transcatheter Pulmonary System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S002
- Product code
- NPV
- Decision date
- 2021-05-21
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- Approval for additional verification of the date of manufacture and use by date for devices undergoing rework activities.
Current openFDA PMA Record#
- Device
- Harmony Transcatheter Pulmonary System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S002
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2021-05-21
- Decision code
- APPR
- Date received
- 2021-04-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for additional verification of the date of manufacture and use by date for devices undergoing rework activities.