OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE— 510(k) K903186

Substantially Equivalent

Telectronics Pacing Systems, Inc.

FDA 510(k) clearance K903186 for OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE, Substantially Equivalent on 1991-01-18. Applicant: Telectronics Pacing Systems, Inc..

Clearance details

Applicant: Telectronics Pacing Systems, Inc.
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1990-07-19
Decision date: 1991-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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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.