PMA supplement
P970015 S019: DUAL INTERFIX-RP(TM) THREADED FUSION DEVICE
FDA PMA supplement · Normal 180 Day Track · Sofamor Danek
Key facts
| Original PMA | P970015 |
|---|---|
| Supplement number | S019 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | DUAL INTERFIX-RP(TM) THREADED FUSION DEVICE |
| Generic name | Intervertebral fusion device with bone graft, lumbar |
| Applicant | Sofamor Danek |
| Product code | MAX |
| Received date | Apr 9, 2001 |
| Decision date | Jul 19, 2001 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: