PMA supplement
P040047 S056: COAPTITE Injectable Implant
FDA PMA supplement · 135 Review Track For 30-Day Notice · Merz North America, Inc.
Key facts
| Original PMA | P040047 |
|---|---|
| Supplement number | S056 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | COAPTITE Injectable Implant |
| Generic name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
| Applicant | Merz North America, Inc. |
| Product code | LNM |
| Received date | Dec 19, 2019 |
| Decision date | Oct 2, 2020 |
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: