PMA supplement
P980035 S384: ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENTHYTHM, KAPPA D (KAPPA 700) IPG & KAPA
FDA PMA supplement · Normal 180 Day Track · Medtronic, Inc.
Key facts
| Original PMA | P980035 |
|---|---|
| Supplement number | S384 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENTHYTHM, KAPPA D (KAPPA 700) IPG & KAPA |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Medtronic, Inc. |
| Product code | LWP |
| Received date | Jul 18, 2014 |
| Decision date | Jan 26, 2015 |
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: