PMA supplement
P950037 S233: Siello S 45/Solia S 45, Siello S 53/Solia S 53, Siello S 60/Solia S 60
FDA PMA supplement · Normal 180 Day Track No User Fee · Biotronik, Inc.
Key facts
| Original PMA | P950037 |
|---|---|
| Supplement number | S233 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | Siello S 45/Solia S 45, Siello S 53/Solia S 53, Siello S 60/Solia S 60 |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | Biotronik, Inc. |
| Product code | DXY |
| Received date | Jan 5, 2022 |
| Decision date | Mar 4, 2022 |
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: