PMA
P040001: X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
FDA PMA · Prosthesis, spinous process spacer/plate · Medtronic Sofamor Danek, Inc.
Key facts
| PMA number | P040001 |
|---|---|
| Trade name | X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM |
| Generic name | Prosthesis, spinous process spacer/plate |
| Applicant | Medtronic Sofamor Danek, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | NQO |
| Approval date | Nov 21, 2005 |
| Docket number | 06M-0014 |
| Notice date | Jan 13, 2006 |
| Establishment registration | 1030489 |
| FEI number | 1000477302 |
At a glance
- 10–99 Supplements
- Dec 12, 2014 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: