PMA supplement
P150012 S095: Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead
FDA PMA supplement · Normal 180 Day Track No User Fee · Boston Scientific
Key facts
| Original PMA | P150012 |
|---|---|
| Supplement number | S095 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Boston Scientific |
| Product code | LWP |
| Received date | May 22, 2020 |
| Decision date | Jun 19, 2020 |
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: