FDA PMA Number P140033, Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software
FDA PMA Number P140033, Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software
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PMA Number: P140033
Device: Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software
Generic Name: Implantable pulse generator, pacemaker (non-CRT)
Manufacturer: Abbott Medical
Product Code:
Date Received: 12/24/2014
Decision Date: 01/31/2017
Notice Date: 03/10/2017
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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