PMA supplement
P150035 S028: AVEIR™ Patient Transmitter (model, LSRM01), AVEIR™ Patient Transmitter Software (model, LSRM1000 v 1.0), AVEIR Patient T
FDA PMA supplement · Normal 180 Day Track · ABBOTT MEDICAL
Key facts
| Original PMA | P150035 |
|---|---|
| Supplement number | S028 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | AVEIR™ Patient Transmitter (model, LSRM01), AVEIR™ Patient Transmitter Software (model, LSRM1000 v 1.0), AVEIR Patient T |
| Generic name | Pacemaker/icd/crt non-implanted components |
| Applicant | ABBOTT MEDICAL |
| Product code | OSR |
| Received date | Jun 27, 2025 |
| Decision date | Sep 24, 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: