PMA P160054S005

Device

HeartMate 3™ Left Ventricular Assist System (LVAS)

Applicant

ABBOTT MEDICAL

PMA number

P160054

Supplement

S005

Product code

DSQ

Decision date

2018-08-24

Classification

Ventricular (assist) Bypass

Generic name

Ventricular (assist) bypass

Approval order statement

Approval for the addition of the Surgical Enhancement Tools, including the Mini Apical Cuff, the Coring Tool, and the Apical Cuff Holder.

Summary

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