PMA supplement
N16420 S004: POLYTEF PASTE FOR VOCAL CORD INJECTION
FDA PMA supplement · Normal 180 Day Track · Coloplast Corp.
Key facts
| Original PMA | N16420 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | POLYTEF PASTE FOR VOCAL CORD INJECTION |
| Generic name | PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION |
| Applicant | Coloplast Corp. |
| Product code | LTG |
| Received date | Dec 24, 1992 |
| Decision date | Dec 8, 1993 |
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: