PMA supplement
P110016 S008: THERAPY COOL FLEX ABLATION CATHETER
FDA PMA supplement · Panel Track · ABBOTT MEDICAL
Key facts
| Original PMA | P110016 |
|---|---|
| Supplement number | S008 |
| Supplement type | Panel Track |
| Trade name | THERAPY COOL FLEX ABLATION CATHETER |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
| Applicant | ABBOTT MEDICAL |
| Product code | OAD |
| Received date | Apr 1, 2013 |
| Decision date | Dec 18, 2013 |
| Docket number | 13M-1693 |
| Notice date | Jan 15, 2014 |
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: