PMA P200046S045

Device: Harmony Transcatheter Pulmonary Valve
Applicant: Medtronic, Inc.
PMA number: P200046
Supplement: S045
Product code: NPV
Decision date: 2026-02-12
Classification: Cardiovascular
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: approval for a Pre-Determined Change Control Plan (PCCP) that establishes a standardized qualification process for new bovine and porcine tissue suppliers, provided they do not impact the tissue's specifications, the established methods for its sourcing, handling, and testing, or the qualification standards for supplier facilities and personnel for the devices under the above PMAs

Current openFDA PMA Record#

Device: Harmony Transcatheter Pulmonary Valve
Applicant: Medtronic, Inc.
PMA number: P200046
Supplement: S045
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2026-02-12
Decision code: APPR
Date received: 2025-09-29
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a Pre-Determined Change Control Plan (PCCP) that establishes a standardized qualification process for new bovine and porcine tissue suppliers, provided they do not impact the tissue's specifications, the established methods for its sourcing, handling, and testing, or the qualification standards for supplier facilities and personnel for the devices under the above PMAs