PMA supplement
P110016 S064: FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled
FDA PMA supplement · Special (Immediate Track) · ABBOTT MEDICAL
Key facts
| Original PMA | P110016 |
|---|---|
| Supplement number | S064 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
| Applicant | ABBOTT MEDICAL |
| Product code | OAD |
| Received date | Sep 12, 2019 |
| Decision date | Oct 9, 2019 |
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: