PMA P200046S048

Device: Harmony™ TPV System
Applicant: Medtronic, Inc.
PMA number: P200046
Supplement: S048
Product code: NPV
Decision date: 2026-03-06
Classification: Cardiovascular
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: Approval of the revised protocols for PAS1, "Continued Follow-up of the Harmony TPV IDE Cohort," and PAS2, "Harmony TPV New Enrollment Study." The PAS protocols have been submitted to comply with the conditions of approval outlined in the approval order for P200046.

Current openFDA PMA Record#

Device: Harmony™ TPV System
Applicant: Medtronic, Inc.
PMA number: P200046
Supplement: S048
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2026-03-06
Decision code: APPR
Date received: 2026-02-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the revised protocols for PAS1, "Continued Follow-up of the Harmony TPV IDE Cohort," and PAS2, "Harmony TPV New Enrollment Study." The PAS protocols have been submitted to comply with the conditions of approval outlined in the approval order for P200046.