PMA supplement
P060039 S083: Attain StarFix Model 4195 Lead
FDA PMA supplement · Normal 180 Day Track No User Fee · Medtronic, Inc.
Key facts
| Original PMA | P060039 |
|---|---|
| Supplement number | S083 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | Attain StarFix Model 4195 Lead |
| Generic name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
| Applicant | Medtronic, Inc. |
| Product code | OJX |
| Received date | Jan 26, 2018 |
| Decision date | Mar 15, 2018 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: