PMA supplement
P010012 S383: ACUITY SPIRAL LEADS
FDA PMA supplement · Normal 180 Day Track · Boston Scientific Corp
Key facts
| Original PMA | P010012 |
|---|---|
| Supplement number | S383 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ACUITY SPIRAL LEADS |
| Generic name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
| Applicant | Boston Scientific Corp |
| Product code | OJX |
| Received date | Dec 22, 2014 |
| Decision date | Mar 19, 2015 |
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: