DeviceClearance

K082730

Substantially Equivalent

AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE

Applicant
American Medical Systems, Inc.
Product code
OTP
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Minnetonka, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OTP

product code OTP
Injury
1,061
Total
1,061

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.