Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

FDA premarket approval P140033 · decided 2017-01-31

Approval details

PMA number

P140033

Trade name

Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Generic name

Implantable pulse generator, pacemaker (non-CRT)

Applicant

ABBOTT MEDICAL

Date received

2014-12-24

Decision date

2017-01-31

Days to decision

769 days

Decision code

APPR

Product code

LWP

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

Approval for the MR Conditional Pacemaker System (which includes the Assurity MRI (Models PM 1272, PM 2272) and Endurity MRI (Models PM 1172, PM 2172) pacemakers, Tendril MRI Lead (Model LPA 1200M), MRI Activator (Model EX4000), Merlin PCS Programmer Software (Model 3330 v 22.1.1), Merlin.net MN5000 7.4d, and Merlin@home EX2000 8.2.2). Implantation of a single-chamber pulse generator or dual-chamber pulse generator is indicated for in one or more of the following permananent conditions:1) Syncop

510(k) clearances by this applicant