PMA
P030017: PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM
FDA PMA · Stimulator, spinal-cord, totally implanted for pain relief · Boston Scientific Corp
Key facts
| PMA number | P030017 |
|---|---|
| Trade name | PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM |
| Generic name | Stimulator, spinal-cord, totally implanted for pain relief |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | LGW |
| Approval date | Apr 27, 2004 |
| Docket number | 04M-0256 |
| Notice date | Jun 10, 2004 |
| Establishment registration | 3006630150 |
| FEI number | 3006630150 |
At a glance
- 100–999 Supplements
- Sep 22, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: