PMA
P160042: REVANESSE ULTRA
FDA PMA · Implant, dermal, for aesthetic use · Prollenium Medical Technologies, Inc.
Key facts
| PMA number | P160042 |
|---|---|
| Trade name | REVANESSE ULTRA |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Prollenium Medical Technologies, Inc. |
| Owner/operator | Prollenium Medical Technologies Inc. |
| Product code | LMH |
| Approval date | Aug 4, 2017 |
| Docket number | 17M-4711 |
| Notice date | Aug 7, 2017 |
| Establishment registration | 3004423487 |
| FEI number | 3004423487 |
At a glance
- 10–99 Supplements
- May 8, 2026 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- No Withdrawn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: