PMA P060040S007

Device: THORATEC HEARTMATE 2 LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S007
Product code: DSQ
Decision date: 2010-04-06
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR A REPAIR KIT (HM II PLRK) FOR THE EXTERNAL PORTION OF THE HEARTMATE II PERCUTANEOUS LEAD AND A REPAIR KIT (CLAM SHELL) FOR THE EXTERNAL BEND RELIEF.

Current openFDA PMA Record#

Device: THORATEC HEARTMATE 2 LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S007
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2010-04-06
Decision code: APPR
Date received: 2010-03-25
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A REPAIR KIT (HM II PLRK) FOR THE EXTERNAL PORTION OF THE HEARTMATE II PERCUTANEOUS LEAD AND A REPAIR KIT (CLAM SHELL) FOR THE EXTERNAL BEND RELIEF.