Cultured Human Cell Skin Dressing
Device Code: 5961
Product Code(s):
PFC Definition: Allogeneic Skin Cells Cultured In Vitro And Combined With Scaffold Sheeting To Act As A Physical Wound Covering And Provide Biological Components That Interact With The Wound, For Treatment Of Skin Ulcers.
Device Classification Information
| Device Type ID | 5961 |
| Device Name | Cultured Human Cell Skin Dressing |
| Physical State | Allogeneic Skin Cells Are Cultured In Vitro And Combined With Scaffold Sheeting |
| Technical Method | Device Funtions As A Physical Wound Covering And Provides Biological Components That Interact With The Wound |
| Target Area | Skin |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PFC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 5961 |
| Device | Cultured Human Cell Skin Dressing |
| Product Code | PFC |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems |
|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
| Total Device Problems | 2 |
TPLC Last Update: 2019-04-02 21:15:18