PMA
P980003: CHILLI COOLED RF ABLATION SYSTEM
FDA PMA · Cardiac ablation percutaneous catheter · Boston Scientific Corp
Key facts
| PMA number | P980003 |
|---|---|
| Trade name | CHILLI COOLED RF ABLATION SYSTEM |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | LPB |
| Approval date | Feb 2, 1999 |
| Docket number | 99M-2016 |
| Notice date | Jun 28, 1999 |
| Establishment registration | 3032507796 |
| FEI number | 3032507796 |
At a glance
- 10–99 Supplements
- Dec 12, 2023 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: