| Device Type ID | 3828 |
| Device Name | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | KGG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3828 |
| Device | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations |
| Product Code | KGG |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 5 |
Appropriate Term/Code Not Available | 4 |
Migration Or Expulsion Of Device | 3 |
Device Operates Differently Than Expected | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
| Total Device Problems | 14 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Codman & Shurtleff, Inc. | I | Jan-23-2014 |