PMA P060040S065

Device: HEARTMATE II LVAS
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S065
Product code: DSQ
Decision date: 2017-06-30
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Approval to revise the Instruction for Use (IFU) for the HeartMate II LVAS to include a summary of results from the PREVENT post-market study, post-approval rates of pump thrombosis, and changes to the clinical management guidelines.

Current openFDA PMA Record#

Device: HEARTMATE II LVAS
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S065
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2017-06-30
Decision code: APPR
Date received: 2017-01-04
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to revise the Instruction for Use (IFU) for the HeartMate II LVAS to include a summary of results from the PREVENT post-market study, post-approval rates of pump thrombosis, and changes to the clinical management guidelines.