PMA
P050046: ACUITY STEERABLE LEAD SYSTEM
FDA PMA · Drug eluting permanent left ventricular (lv) pacemaker electrode · Guidant Corp.
Key facts
| PMA number | P050046 |
|---|---|
| Trade name | ACUITY STEERABLE LEAD SYSTEM |
| Generic name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
| Applicant | Guidant Corp. |
| Owner/operator | Boston Scientific Corporation |
| Product code | OJX |
| Approval date | Apr 13, 2007 |
| Docket number | 07M-0154 |
| Notice date | Apr 19, 2007 |
| Establishment registration | 2124215 |
| FEI number | 2124215 |
At a glance
- 10–99 Supplements
- Sep 24, 2021 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- No Withdrawn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: