PMA supplement
P010012 S407: ACUITY SPIRAL LEAD MODELS
FDA PMA supplement · 135 Review Track For 30-Day Notice · Boston Scientific Corp
Key facts
| Original PMA | P010012 |
|---|---|
| Supplement number | S407 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ACUITY SPIRAL LEAD MODELS |
| Generic name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
| Applicant | Boston Scientific Corp |
| Product code | OJX |
| Received date | Nov 20, 2015 |
| Decision date | Apr 29, 2016 |
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: