PMA supplement
P030017 S295: Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cord Stimulato
FDA PMA supplement · Normal 180 Day Track No User Fee · Boston Scientific Corp
Key facts
| Original PMA | P030017 |
|---|---|
| Supplement number | S295 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cord Stimulato |
| Generic name | Stimulator, spinal-cord, totally implanted for pain relief |
| Applicant | Boston Scientific Corp |
| Product code | LGW |
| Received date | May 30, 2017 |
| Decision date | Nov 22, 2017 |
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: