PMA
N16420: MENTOR POLYTEF PASTE FOR INJECTION
FDA PMA · PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION · Coloplast Corp.
Key facts
| PMA number | N16420 |
|---|---|
| Trade name | MENTOR POLYTEF PASTE FOR INJECTION |
| Generic name | PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION |
| Applicant | Coloplast Corp. |
| Owner/operator | Coloplast Corp. |
| Product code | LTG |
| Approval date | Jan 20, 1972 |
| Establishment registration | 2125050 |
| FEI number | 2125050 |
At a glance
- 1–9 Supplements
- Jan 3, 2005 Latest supplement decision
- Yes Withdrawn
- No 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: