AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM— 510(k) K080185
Substantially EquivalentAmerican Medical Systems, Inc.
FDA 510(k) clearance K080185 for AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM, Substantially Equivalent on 2008-04-10. Applicant: American Medical Systems, Inc..
Clearance details
- Applicant
- American Medical Systems, Inc.
- Product code
- Code OTP
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- 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, 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.