PMA supplement
P160042 S017: Revanesse Versa+ with Lidocaine (1.0 mL and 1.2 mL) and Revanesse Lips+ with Lidocaine (1.0 mL and 1.2 mL)
FDA PMA supplement · 135 Review Track For 30-Day Notice · Prollenium Medical Technologies, Inc.
Key facts
| Original PMA | P160042 |
|---|---|
| Supplement number | S017 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Revanesse Versa+ with Lidocaine (1.0 mL and 1.2 mL) and Revanesse Lips+ with Lidocaine (1.0 mL and 1.2 mL) |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Prollenium Medical Technologies, Inc. |
| Product code | LMH |
| Received date | Oct 5, 2021 |
| Decision date | Apr 20, 2022 |
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: