PMA
P060018: PRESTIGE CERVICAL DISC SYSTEM
FDA PMA · Prosthesis, intervertebral disc · Medtronic Sofamor Danek, Inc.
Key facts
| PMA number | P060018 |
|---|---|
| Trade name | PRESTIGE CERVICAL DISC SYSTEM |
| Generic name | Prosthesis, intervertebral disc |
| Applicant | Medtronic Sofamor Danek, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | MJO |
| Approval date | Jul 16, 2007 |
| Docket number | 07M-0289 |
| Notice date | Jul 20, 2007 |
| Establishment registration | 1030489 |
| FEI number | 1000477302 |
At a glance
- 1–9 Supplements
- Aug 11, 2016 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- Yes Withdrawn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: