PMA P200046S043
- Device
- Harmony™ TPV System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S043
- Product code
- NPV
- Decision date
- 2025-09-05
- Classification
- Cardiovascular
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- Approval for a revision to the Instructions for Use to add a warning statement related to inspection of the valve container for damage.
Current openFDA PMA Record#
- Device
- Harmony™ TPV System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S043
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2025-09-05
- Decision code
- APPR
- Date received
- 2025-08-06
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a revision to the Instructions for Use to add a warning statement related to inspection of the valve container for damage.