PMA supplement
P110016 S080: FlexAbility™ Ablation Catheter, Sensor Enabled™
FDA PMA supplement · Panel Track · ABBOTT MEDICAL
Key facts
| Original PMA | P110016 |
|---|---|
| Supplement number | S080 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | FlexAbility™ Ablation Catheter, Sensor Enabled™ |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | ABBOTT MEDICAL |
| Product code | LPB |
| Received date | Apr 11, 2022 |
| Decision date | Dec 14, 2022 |
| Docket number | 22M-3254 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: