PMA supplement
P880086 S344: P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256,
FDA PMA supplement · 30-Day Notice · ABBOTT MEDICAL
Key facts
| Original PMA | P880086 |
|---|---|
| Supplement number | S344 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256, |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | ABBOTT MEDICAL |
| Product code | DXY |
| Received date | May 29, 2025 |
| Decision date | Jun 18, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: