K182169

Substantially Equivalent

AdVance XP Male Sling

Applicant
Boston Scientific Corporation
Product code
OTM
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minnetonka, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OTM

product code OTM
Injury
760
Total
760

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.