PMA
P000020: STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE
FDA PMA · Cardiac ablation percutaneous catheter · Boston Scientific Corp
Key facts
| PMA number | P000020 |
|---|---|
| Trade name | STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | LPB |
| Approval date | Nov 29, 2000 |
| Docket number | 01M-0460 |
| Notice date | Oct 11, 2001 |
| Establishment registration | 9616684 |
| FEI number | 3002913962 |
At a glance
- 10–99 Supplements
- Jun 4, 2014 Latest supplement decision
- No Withdrawn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: