PMA
BP170122: ReCell Autologous Cell Harvesting Device
FDA PMA · Mechanical and enzymatic autologous skin processor for cell suspension, with applicator · Avita Medical
Key facts
| PMA number | BP170122 |
|---|---|
| Trade name | ReCell Autologous Cell Harvesting Device |
| Generic name | Mechanical and enzymatic autologous skin processor for cell suspension, with applicator |
| Applicant | Avita Medical |
| Owner/operator | Avita Medical Americas LLC |
| Product code | QCZ |
| Approval date | Sep 20, 2018 |
| Establishment registration | 3014270795 |
| FEI number | 3014270795 |
At a glance
- 10–99 Supplements
- Jun 7, 2023 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: