PMA P100047S033

Device: HEART WARE VENTRICULAR ASSIST SYSTEM
Applicant: Medtronic
PMA number: P100047
Supplement: S033
Product code: DSQ
Decision date: 2014-02-13
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR USE OF A NEW FORMULATION OF THE THERMOPLASTICVULCANIZATE (TPZ) MATERIAL USED IN THE MANUFACTURE OF THE MONITOR DATA CABLE, BATTERY PACK CABLE, DC ADAPTOR INPUT CABLE, AND ALARM SILENCE ADAPTOR COMPONENTS OF THE DEVICE.

Current openFDA PMA Record#

Device: HEART WARE VENTRICULAR ASSIST SYSTEM
Applicant: Medtronic
PMA number: P100047
Supplement: S033
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2014-02-13
Decision code: APPR
Date received: 2013-11-18
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR USE OF A NEW FORMULATION OF THE THERMOPLASTICVULCANIZATE (TPZ) MATERIAL USED IN THE MANUFACTURE OF THE MONITOR DATA CABLE, BATTERY PACK CABLE, DC ADAPTOR INPUT CABLE, AND ALARM SILENCE ADAPTOR COMPONENTS OF THE DEVICE.