| Device Type ID | 4117 |
| Device Name | Barrier, Absorbable, Adhesion |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MCN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4117 |
| Device | Barrier, Absorbable, Adhesion |
| Product Code | MCN |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 83 |
Adverse Event Without Identified Device Or Use Problem | 70 |
Migration Or Expulsion Of Device | 27 |
Defective Device | 7 |
Material Erosion | 5 |
Unsealed Device Packaging | 5 |
Device Markings / Labelling Problem | 2 |
Insufficient Information | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Incomplete Or Missing Packaging | 1 |
Device Issue | 1 |
Failure To Adhere Or Bond | 1 |
Obstruction Of Flow | 1 |
| Total Device Problems | 205 |