PMA P920014S015

Device: HEARTMATE XVE LVAS
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S015
Product code: DSQ
Decision date: 2001-05-31
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL TO INCLUDE THE HEARTMATE. XVE LVAS UNDER P920014, WITH THE SAME INDICATIONS FOR USE AS FOR THE PREVIOUSLY APPROVED (IN SUPPLEMENT S7, APPROVAL LETTER DATED OCTOBER 6, 1998) VE LVAS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEARTMATE. XVE LVAS AND IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FAILURE. THE HEARTMATE. SVE LVAS IS INDICATED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL.

Current openFDA PMA Record

Device: HEARTMATE XVE LVAS
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S015
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2001-05-31
Decision code: APPR
Date received: 2001-02-23
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO INCLUDE THE HEARTMATE. XVE LVAS UNDER P920014, WITH THE SAME INDICATIONS FOR USE AS FOR THE PREVIOUSLY APPROVED (IN SUPPLEMENT S7, APPROVAL LETTER DATED OCTOBER 6, 1998) VE LVAS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEARTMATE. XVE LVAS AND IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FAILURE. THE HEARTMATE. SVE LVAS IS INDICATED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL.