PMA supplement
P910023 S406: Fortify Models CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q; Fortify Assura Models CD1257-40, CD1257-40Q, CD2257-40, CD2
FDA PMA supplement · 30-Day Notice · ABBOTT MEDICAL
Key facts
| Original PMA | P910023 |
|---|---|
| Supplement number | S406 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Fortify Models CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q; Fortify Assura Models CD1257-40, CD1257-40Q, CD2257-40, CD2 |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | ABBOTT MEDICAL |
| Product code | LWS |
| Received date | Mar 12, 2018 |
| Decision date | Apr 4, 2018 |
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: