PMA supplement
P110016 S025: FLEXABILITY ABLATION CATHETER, SENSOR ENABLED
FDA PMA supplement · Normal 180 Day Track · ABBOTT MEDICAL
Key facts
| Original PMA | P110016 |
|---|---|
| Supplement number | S025 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | FLEXABILITY ABLATION CATHETER, SENSOR ENABLED |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
| Applicant | ABBOTT MEDICAL |
| Product code | OAD |
| Received date | Nov 5, 2015 |
| Decision date | Feb 17, 2017 |
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: