MELODY TRANSCATHETER PULMONARY VALVE, ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM and ENSEMBLE II TRANSCATHETER VALVE D

FDA premarket approval P140017/S005 · decided 2017-02-24

Approval details

PMA number

P140017

Supplement

S005

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

MELODY TRANSCATHETER PULMONARY VALVE, ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM and ENSEMBLE II TRANSCATHETER VALVE D

Generic name

Pulmonary valve prosthesis percutaneously delivered

Applicant

Medtronic, Inc.

Date received

2016-09-01

Decision date

2017-02-24

Days to decision

176 days

Decision code

APPR

Product code

NPV

Advisory committee

Cardiovascular

Expedited review

Yes

Location

Mounds View, MN

Statement

Approval for the Melody Transcatheter Pulmonary Valve, Ensemble Transcatheter Valve Delivery System, and Ensemble II Transcatheter Valve Delivery System for expanding the indications to include patients with a dysfunctional surgical bioprosthetic pulmonary valve. The device is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic pulmonary valv

510(k) clearances by this applicant