PMA
P990054: CHILLI COOLED ABLATION SYSTEM
FDA PMA · Cardiac ablation percutaneous catheter · Boston Scientific Corp
Key facts
| PMA number | P990054 |
|---|---|
| Trade name | CHILLI COOLED ABLATION SYSTEM |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | LPB |
| Approval date | Mar 17, 2000 |
| Docket number | 00M-1517 |
| Notice date | Sep 26, 2000 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 1–9 Supplements
- Jun 13, 2006 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: