PMA P100047S115

Device: HeartWare HVAD System
Applicant: Medtronic
PMA number: P100047
Supplement: S115
Product code: DSQ
Decision date: 2018-07-26
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: This device is indicated for hemodynamic support in patients with advanced, refractory leftventricular heart failure; either as a bridge to cardiac transplantation (BTT), myocardial recovery, or as destination therapy (DT) in patients for whom subsequent transplantation is not planned. We are pleased to inform you that the PMA supplement is approved.

Current openFDA PMA Record#

Device: HeartWare HVAD System
Applicant: Medtronic
PMA number: P100047
Supplement: S115
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2018-07-26
Decision code: APPR
Date received: 2017-10-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: This device is indicated for hemodynamic support in patients with advanced, refractory leftventricular heart failure; either as a bridge to cardiac transplantation (BTT), myocardial recovery, or as destination therapy (DT) in patients for whom subsequent transplantation is not planned. We are pleased to inform you that the PMA supplement is approved.