| Device Type ID | 5933 |
| Device Name | Device, Dermal Replacement |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MDD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5933 |
| Device | Device, Dermal Replacement |
| Product Code | MDD |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 6 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Appropriate Term/Code Not Available | 3 |
Material Integrity Problem | 2 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Device Expiration Issue | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Folded | 1 |
Patient Device Interaction Problem | 1 |
Material Twisted / Bent | 1 |
Patient-Device Incompatibility | 1 |
Shipping Damage Or Problem | 1 |
| Total Device Problems | 25 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Integra LifeSciences Corporation | II | Sep-09-2016 |