PMA supplement
P010047 S036: PROGEL PLEURAL AIR LEAK SEALANT
FDA PMA supplement · Panel Track · Neomend, Inc.
Key facts
| Original PMA | P010047 |
|---|---|
| Supplement number | S036 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PROGEL PLEURAL AIR LEAK SEALANT |
| Generic name | Sealant, polymerizing |
| Applicant | Neomend, Inc. |
| Product code | NBE |
| Received date | Jul 11, 2014 |
| Decision date | Feb 13, 2015 |
| Docket number | 15M-0502 |
| Notice date | Mar 19, 2015 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: