DeviceClearance

K192460

Substantially Equivalent

Sentinel Cerebral Protection System

Applicant
Boston Scientific Corporation
Product code
PUM
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Maple Grove, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code PUM

product code PUM
Death
3
Total
3

Source: openFDA MAUDE database, through . 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.