PMA P200046S052
- Device
- Harmony TPV System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S052
- Product code
- NPV
- Decision date
- 2026-09-30
- Classification
- Cardiovascular
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- an update to the flash-trimming process of the Inner Shaft and Tip subassembly of the Harmony Delivery Catheter System
Current openFDA PMA Record#
- Device
- Harmony TPV System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S052
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2026-09-30
- Decision code
- OK30
- Date received
- 2026-09-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update to the flash-trimming process of the Inner Shaft and Tip subassembly of the Harmony Delivery Catheter System