PMA supplement
P100030 S008: PreveLeak Surgical Sealant
FDA PMA supplement · Panel Track · Baxter Healthcare Corporation
Key facts
| Original PMA | P100030 |
|---|---|
| Supplement number | S008 |
| Supplement type | Panel Track |
| 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 | Jul 3, 2017 |
| Decision date | Dec 21, 2017 |
| Docket number | 17M-6971 |
| Notice date | Jan 9, 2018 |
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: