PMA
P140004: SUPERION INTERSPINOUS SPACER
FDA PMA · Prosthesis, spinous process spacer/plate · Boston Scientific Neuromodulation
Key facts
| PMA number | P140004 |
|---|---|
| Trade name | SUPERION INTERSPINOUS SPACER |
| Generic name | Prosthesis, spinous process spacer/plate |
| Applicant | Boston Scientific Neuromodulation |
| Owner/operator | Boston Scientific Corporation |
| Product code | NQO |
| Approval date | May 20, 2015 |
| Docket number | 15M-1957 |
| Notice date | Jun 18, 2015 |
| Establishment registration | 3006630150 |
| FEI number | 3006630150 |
At a glance
- 10–99 Supplements
- Nov 7, 2024 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: