PMA
P050033: HYDRELLE
FDA PMA · Implant, dermal, for aesthetic use · Anika Therapeutics, Inc.
Key facts
| PMA number | P050033 |
|---|---|
| Trade name | HYDRELLE |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Anika Therapeutics, Inc. |
| Owner/operator | ANIKA THERAPEUTICS, INC. |
| Product code | LMH |
| Approval date | Dec 20, 2006 |
| Docket number | 06M-0531 |
| Notice date | Dec 26, 2006 |
| Establishment registration | 3007093114 |
| FEI number | 3007093114 |
At a glance
- 10–99 Supplements
- Nov 3, 2015 Latest supplement decision
- No Withdrawn
- Yes 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: