PMA supplement
P990001 S024: VITATRON C60 DR MODEL C60A3, VITATRON C20 SR MODEL C20A3, VITATRON T60 DR MODEL T60A1, AND VITATRON T20 SR MODEL T20A1
FDA PMA supplement · Real-Time Process · Medtronic, Inc.
Key facts
| Original PMA | P990001 |
|---|---|
| Supplement number | S024 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | VITATRON C60 DR MODEL C60A3, VITATRON C20 SR MODEL C20A3, VITATRON T60 DR MODEL T60A1, AND VITATRON T20 SR MODEL T20A1 |
| Generic name | Pulse generator, permanent, implantable |
| Applicant | Medtronic, Inc. |
| Product code | NVZ |
| Received date | Jan 19, 2006 |
| Decision date | Mar 31, 2006 |
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: