PMA supplement
BP170122 S221: ReCell Autologous Cell Harvesting Device
FDA PMA supplement · 135 Day Track for 30 Day Notification · Avita Medical
Key facts
| Original PMA | BP170122 |
|---|---|
| Supplement number | S221 |
| Supplement type | 135 Day Track for 30 Day Notification |
| Trade name | ReCell Autologous Cell Harvesting Device |
| Generic name | Mechanical and enzymatic autologous skin processor for cell suspension, with applicator |
| Applicant | Avita Medical |
| Product code | QCZ |
| Received date | May 22, 2020 |
| Decision date | Aug 23, 2020 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: