PMA supplement
P910023 S312: ATLAS/ATLAS+, ATLAS II/ATLAS II+, CURRENT, CURRENT ACCEL, CURRENT+, EPIC/EPIC+, EPIC II/EPIC II+, FORTIFY
FDA PMA supplement · 135 Review Track For 30-Day Notice · ABBOTT MEDICAL
Key facts
| Original PMA | P910023 |
|---|---|
| Supplement number | S312 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ATLAS/ATLAS+, ATLAS II/ATLAS II+, CURRENT, CURRENT ACCEL, CURRENT+, EPIC/EPIC+, EPIC II/EPIC II+, FORTIFY |
| Generic name | Pulse generator, permanent, implantable |
| Applicant | ABBOTT MEDICAL |
| Product code | NVZ |
| Received date | Dec 11, 2012 |
| Decision date | Apr 23, 2013 |
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: