510(k) K894185— OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR

Substantially Equivalent

Telectronics Pacing Systems, Inc.

Clearance details

Applicant: Telectronics Pacing Systems, Inc.
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1989-06-16
Decision date: 1989-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Adverse events under product code DXY

product code DXY

Death: 240
Injury: 2,328
Malfunction: 2,096
Total: 4,664

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.