PMA supplement
P010047 S065: PROGEL Pleural Air Leak Sealant
FDA PMA supplement · Normal 180 Day Track No User Fee · Neomend, Inc.
Key facts
| Original PMA | P010047 |
|---|---|
| Supplement number | S065 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | PROGEL Pleural Air Leak Sealant |
| Generic name | Sealant, polymerizing |
| Applicant | Neomend, Inc. |
| Product code | NBE |
| Received date | Mar 2, 2021 |
| Decision date | Feb 9, 2022 |
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: