PMA supplement
N16420 S005: POLYTEF PASTE FOR INJECTION
FDA PMA supplement · Normal 180 Day Track · Coloplast Corp.
Key facts
| Original PMA | N16420 |
|---|---|
| Supplement number | S005 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | POLYTEF PASTE FOR INJECTION |
| Generic name | PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION |
| Applicant | Coloplast Corp. |
| Product code | LTG |
| Received date | Dec 26, 2000 |
| Decision date | May 30, 2001 |
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: