PMA supplement
P200022 S003: Simplify Cervical Artificial Disc
FDA PMA supplement · Panel Track · Globus Medical, Inc.
Key facts
| Original PMA | P200022 |
|---|---|
| Supplement number | S003 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Simplify Cervical Artificial Disc |
| Generic name | Prosthesis, intervertebral disc |
| Applicant | Globus Medical, Inc. |
| Product code | MJO |
| Received date | Oct 27, 2020 |
| Decision date | Apr 1, 2021 |
| Docket number | 21M-0355 |
| Notice date | Apr 12, 2021 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: