PMA
P140033: Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software
FDA PMA · Implantable pulse generator, pacemaker (non-CRT) · ABBOTT MEDICAL
Key facts
| 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 |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LWP |
| Approval date | Jan 31, 2017 |
| Docket number | 17M-0661 |
| Notice date | Mar 10, 2017 |
| Establishment registration | 2017865 |
| FEI number | 2017865 |
At a glance
- 100–999 Supplements
- Jul 21, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: