# ABBOTT MEDICAL: PMA supplement approved for UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isof

**Score:** 30/100

| Field | Value |
|---|---|
| Sponsor | ABBOTT MEDICAL |
| Product | UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten |
| Generic / ingredient | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
| Approval | PMA supplement (device change) |
| Application | P960013 S133 |
| Decided | 2026-06-11 |
| Panel / class | Cardiovascular |
| Sponsor location | Sylmar, CA |

## Why this score


Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960013S133). Last refreshed: 2026-11-04T06:06:18.796Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.