PMA P060040S002

Device: THORATEC HEARTMATE II LVAS
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S002
Product code: DSQ
Decision date: 2008-12-03
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR THE ADDITION OF A CAUTION STATEMENT ''WARNING: PRECLOT THEGRAFT!" TO THE PACKAGE LABELS FOR THE OUTFLOW GRAFT WITH BEND RELIEF (CATALOG# 102563) ANDINFLOW CONDUIT (CATALOG # 102564). THIS CAUTION STATEMENT IS TO HIGHLIGHT INFORMATION CURRENTLYFOUND IN THE HEARTMATE II INSTRUCTIONS FOR USE, SECTION 13.4, WHICH INSTRUCTS USERS TO PRE-CLOT THE TWO COMPONENTS PRIOR TO IMPLANTATION.

Current openFDA PMA Record#

Device: THORATEC HEARTMATE II LVAS
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S002
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2008-12-03
Decision code: APPR
Date received: 2008-11-20
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF A CAUTION STATEMENT ''WARNING: PRECLOT THEGRAFT!" TO THE PACKAGE LABELS FOR THE OUTFLOW GRAFT WITH BEND RELIEF (CATALOG# 102563) ANDINFLOW CONDUIT (CATALOG # 102564). THIS CAUTION STATEMENT IS TO HIGHLIGHT INFORMATION CURRENTLYFOUND IN THE HEARTMATE II INSTRUCTIONS FOR USE, SECTION 13.4, WHICH INSTRUCTS USERS TO PRE-CLOT THE TWO COMPONENTS PRIOR TO IMPLANTATION.