K983552

Substantially Equivalent

BASIC, MEDIAN, DOMINANT, AND VARIO

Applicant: Medela, Inc.
Product code: BTA
Advisory panel: General, Plastic Surgery
Date received: 1998-10-09
Decision date: 1999-01-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mchenry, IL, US

Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.