K121612

Substantially Equivalent

ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION

Applicant: American Medical Systems
Product code: OTP
Advisory panel: Obstetrics/Gynecology
Date received: 2012-06-01
Decision date: 2012-07-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

Adverse events under product code OTP

product code OTP

Injury: 1,061
Total: 1,061

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.