PMA supplement
P960009 S054: SOLETRA, KINETRA IMPLANTABLE NEUROSTIMULATOR
FDA PMA supplement · 135 Review Track For 30-Day Notice · Medtronic, Inc.
Key facts
| Original PMA | P960009 |
|---|---|
| Supplement number | S054 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | SOLETRA, KINETRA IMPLANTABLE NEUROSTIMULATOR |
| Generic name | Stimulator, electrical, implanted, for parkinsonian tremor |
| Applicant | Medtronic, Inc. |
| Product code | MHY |
| Received date | Jun 30, 2008 |
| Decision date | Dec 4, 2009 |
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: