MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)

FDA premarket approval P140017 · decided 2015-01-27

Approval details

PMA number

P140017

Trade name

MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)

Generic name

Pulmonary valve prosthesis percutaneously delivered

Applicant

Medtronic, Inc.

Date received

2014-08-21

Decision date

2015-01-27

Days to decision

159 days

Decision code

APPR

Product code

NPV

Advisory committee

Cardiovascular

Expedited review

Yes

Location

Mounds View, MN

Statement

APPROVAL THE MELODY TRANSCATHETER PULMONARY VALVE (TPV) AND THE ENSEMBLE TRANSCATHETER VALVE DELIVERYSYSTEM. THIS DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO SURGERY IN THE MANAGEMENT OF PEDIATRIC AND ADULT PATIENTS WITH THE FOLLOWING CLINICAL CONDITIONS:1) EXISTENCE OF A FULL (CIRCUMFERENTIAL) RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) CONDUIT THAT WAS EQUAL TO OR GREATER THAN 16 MM IN DIAMETER WHEN ORIGINALLY IMPLANTED, AND 2) DYSFUNCTIONAL RVOT CONDUIT WITH A CLINICAL INDICATION FOR INTERVENTION

510(k) clearances by this applicant