PMA supplement
P960004 S089: Accessory Stylet TAPER.014 45CM,.014 52CM,.014 58CM,.016 45CM,.016 52CM, and.016 58CM, Accessory Stylet TAPER.013
FDA PMA supplement · 30-Day Notice · Boston Scientific
Key facts
| Original PMA | P960004 |
|---|---|
| Supplement number | S089 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Accessory Stylet TAPER .014 45CM, .014 52CM, .014 58CM, .016 45CM, .016 52CM, and .016 58CM, Accessory Stylet TAPER .013 |
| Generic name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
| Applicant | Boston Scientific |
| Product code | NVN |
| Received date | Mar 13, 2019 |
| Decision date | Apr 8, 2019 |
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: