AMS ELEVATE PC— 510(k) K112842
Substantially EquivalentAmerican Medical Systems, Inc.
FDA 510(k) clearance K112842 for AMS ELEVATE PC, Substantially Equivalent on 2011-10-25. Applicant: American Medical Systems, Inc.. Device class: 3.
Clearance details
- Applicant
- American Medical Systems, Inc.
- Product code
- Code OTP
- Device class
- Class 3
- Regulation
- 21 CFR 884.5980
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minnetonka, MN, US
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- K102815 — SURELIFT PROLAPSE SYSTEM
More clearances from American Medical Systems, Inc.
view allAdverse 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.