PMA supplement
P010040 S001: THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE
FDA PMA supplement · Real-Time Process · Redhawk Medical Products & Services, LLC
Key facts
| Original PMA | P010040 |
|---|---|
| Supplement number | S001 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE |
| Generic name | Sharps needle destruction device |
| Applicant | Redhawk Medical Products & Services, LLC |
| Product code | MTV |
| Received date | Apr 16, 2002 |
| Decision date | Apr 18, 2002 |
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: