PMA supplement
P910073 S180: LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR AF SC,
FDA PMA supplement · 30-Day Notice · Boston Scientific
Key facts
| Original PMA | P910073 |
|---|---|
| Supplement number | S180 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR AF SC, |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Boston Scientific |
| Product code | LWS |
| Received date | Nov 6, 2024 |
| Decision date | Nov 7, 2024 |
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: