PMA supplement
P960013 S130: OptiSense 1999; Tendril SDX Lead 1688T/TC DTB; Tendril ST Lead 1888TC, 1882TC; Tendril STS Lead 2088TC; Tendril STS Lead
FDA PMA supplement · 30-Day Notice · ABBOTT MEDICAL
Key facts
| Original PMA | P960013 |
|---|---|
| Supplement number | S130 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | OptiSense 1999; Tendril SDX Lead 1688T/TC DTB; Tendril ST Lead 1888TC, 1882TC; Tendril STS Lead 2088TC; Tendril STS Lead |
| Generic name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
| Applicant | ABBOTT MEDICAL |
| Product code | NVN |
| Received date | May 29, 2025 |
| Decision date | Jun 18, 2025 |
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: