510(k) K853410— MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD

Substantially Equivalent

Intermedics, Inc.

Clearance details

Applicant: Intermedics, Inc.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 1985-08-13
Decision date: 1985-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freeport, TX, US

Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.