PMA supplement
P030017 S363: Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System
FDA PMA supplement · Panel Track · Boston Scientific Corp
Key facts
| Original PMA | P030017 |
|---|---|
| Supplement number | S363 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System |
| Generic name | Stimulator, spinal-cord, totally implanted for pain relief |
| Applicant | Boston Scientific Corp |
| Product code | LGW |
| Received date | May 30, 2023 |
| Decision date | Feb 5, 2024 |
| Docket number | 24M-0603 |
| Notice date | Feb 21, 2024 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: