PMA supplement
P100030 S004: PREVELEAK SURGICAL SEALANT
FDA PMA supplement · Normal 180 Day Track No User Fee · Baxter Healthcare Corporation
Key facts
| Original PMA | P100030 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PREVELEAK SURGICAL SEALANT |
| Generic name | Sealant, polymerizing |
| Applicant | Baxter Healthcare Corporation |
| Product code | NBE |
| Received date | May 22, 2014 |
| Decision date | Jul 31, 2014 |
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: