PMA
P950022: TVL(TM) LEAD SYSTEM
FDA PMA · Implantable cardioverter defibrillator (non-CRT) · ABBOTT MEDICAL
Key facts
| PMA number | P950022 |
|---|---|
| Trade name | TVL(TM) LEAD SYSTEM |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LWS |
| Approval date | May 10, 1996 |
| Docket number | 97M-0460 |
| Notice date | Nov 19, 1997 |
| Establishment registration | 2017865 |
| FEI number | 2017865 |
At a glance
- 100–999 Supplements
- Jun 26, 2026 Latest supplement decision
- No Withdrawn
- No 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: