PMA supplement
P090029 S003: PRESTIGE LP(TM) CERVICAL DISC
FDA PMA supplement · Panel Track · Medtronic Sofamor Danek USA, Inc.
Key facts
| Original PMA | P090029 |
|---|---|
| Supplement number | S003 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PRESTIGE LP(TM) CERVICAL DISC |
| Generic name | Prosthesis, intervertebral disc |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Product code | MJO |
| Received date | Jun 3, 2015 |
| Decision date | Jul 7, 2016 |
| Docket number | 16M-2182 |
| Notice date | Jul 25, 2016 |
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: