PMA supplement
N970003 S245: Essentio SR/DR SL, Essentio DR EL, Proponent SR/DR SL, Proponent DR EL, Accolade SR/DR SL, Accolade DR EL, Altrua 2 SR/D
FDA PMA supplement · 30-Day Notice · Boston Scientific Corp
Key facts
| Original PMA | N970003 |
|---|---|
| Supplement number | S245 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Essentio SR/DR SL, Essentio DR EL, Proponent SR/DR SL, Proponent DR EL, Accolade SR/DR SL, Accolade DR EL, Altrua 2 SR/D |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Boston Scientific Corp |
| Product code | LWP |
| Received date | Nov 22, 2019 |
| Decision date | Nov 27, 2019 |
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: