PMA supplement
P960013 S095: Tendril SDX Lead, Tendril ST Lead, OptiSense, Tentril STS Lead
FDA PMA supplement · 30-Day Notice · ABBOTT MEDICAL
Key facts
| Original PMA | P960013 |
|---|---|
| Supplement number | S095 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Tendril SDX Lead, Tendril ST Lead, OptiSense, Tentril STS Lead |
| Generic name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
| Applicant | ABBOTT MEDICAL |
| Product code | NVN |
| Received date | Jan 31, 2018 |
| Decision date | Feb 22, 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: