PMA
P100012: NUVASIVE PCM CERVICAL DISC SYSTEM
FDA PMA · Prosthesis, intervertebral disc · Nuvasive, Inc.
Key facts
| PMA number | P100012 |
|---|---|
| Trade name | NUVASIVE PCM CERVICAL DISC SYSTEM |
| Generic name | Prosthesis, intervertebral disc |
| Applicant | Nuvasive, Inc. |
| Owner/operator | NUVASIVE, INC. |
| Product code | MJO |
| Approval date | Oct 26, 2012 |
| Docket number | 12M-1111 |
| Notice date | Nov 8, 2012 |
| Establishment registration | 2031966 |
| FEI number | 3002980729 |
At a glance
- 1–9 Supplements
- Apr 3, 2019 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- Yes Withdrawn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: