PMA supplement
P980035 S382: ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPPA 900, RELIA, SENSIA, SIGMA,
FDA PMA supplement · Real-Time Process · Medtronic, Inc.
Key facts
| Original PMA | P980035 |
|---|---|
| Supplement number | S382 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPPA 900, RELIA, SENSIA, SIGMA, |
| Generic name | Pulse generator, permanent, implantable |
| Applicant | Medtronic, Inc. |
| Product code | NVZ |
| Received date | Jul 2, 2014 |
| Decision date | Sep 5, 2014 |
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: