Definition: For Treatment Of Fecal Incontinence In Patients Who Have Failed Conservative Therapies
| Device Type ID | 2234 |
| Device Name | Mechanical Compression Device Fecal Incontinence (non-manually Operated) |
| Physical State | The Device Is Comprised Of An Annular Ring (implant), Sizing Tool And Insertion Tool. |
| Technical Method | Compresseion Of The Anal Sphincter Through Use Of Magnetic Force |
| Target Area | External Anal Sphincter. |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | PMH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2234 |
| Device | Mechanical Compression Device Fecal Incontinence (non-manually Operated) |
| Product Code | PMH |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 51 |
Device-Device Incompatibility | 1 |
| Total Device Problems | 52 |