MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191— 510(k) K100807
Substantially EquivalentAmerican Medical Systems, Inc.
FDA 510(k) clearance K100807 for MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191, Substantially Equivalent on 2010-06-07. Applicant: American Medical Systems, Inc..
Clearance details
- Applicant
- American Medical Systems, Inc.
- Product code
- Code PAH
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnetonka, MN, US
Adverse events under product code PAH
product code PAH- Injury
- 886
- Malfunction
- 529
- Total
- 1,415
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.