PMA supplement
P910023 S358: CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICDS
FDA PMA supplement · Real-Time Process · ABBOTT MEDICAL
Key facts
| Original PMA | P910023 |
|---|---|
| Supplement number | S358 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICDS |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | ABBOTT MEDICAL |
| Product code | LWS |
| Received date | Jul 23, 2015 |
| Decision date | Sep 16, 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: