PMA supplement
N970003 S223: Ingenio Pacemakers (Advantio, Ingenio, Vitalio, Formio / Ingenio 2 Pacemakers (Altrua 2, Essentio, Proponent, Accolade)
FDA PMA supplement · Real-Time Process · Boston Scientific Corp
Key facts
| Original PMA | N970003 |
|---|---|
| Supplement number | S223 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Ingenio Pacemakers (Advantio, Ingenio, Vitalio, Formio / Ingenio 2 Pacemakers (Altrua 2, Essentio, Proponent, Accolade) |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Boston Scientific Corp |
| Product code | LWP |
| Received date | Dec 14, 2017 |
| Decision date | Feb 2, 2018 |
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: