SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS— 510(k) K041948
Substantially EquivalentAmerican Medical Systems, Inc.
FDA 510(k) clearance K041948 for SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS, Substantially Equivalent on 2004-08-11. Applicant: American Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- American Medical Systems, Inc.
- Product code
- Code OTN
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minnetonka, MN, US
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More clearances from American Medical Systems, Inc.
view allAdverse events under product code OTN
product code OTN- Injury
- 6,630
- Total
- 6,630
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.