PMA
P070013: EVOLENCE COLLAGEN FILLER
FDA PMA · Implant, dermal, for aesthetic use · Colbar Lifescience, Ltd.
Key facts
| PMA number | P070013 |
|---|---|
| Trade name | EVOLENCE COLLAGEN FILLER |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Colbar Lifescience , Ltd. |
| Product code | LMH |
| Approval date | Jun 27, 2008 |
| Docket number | 08M-0402 |
| Notice date | Jul 16, 2008 |
| FEI number | 3005654090 |
At a glance
- 1–9 Supplements
- Jun 5, 2009 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: