PMA supplement
P220014 S001: CraniSeal Dural Sealant
FDA PMA supplement · Normal 180 Day Track No User Fee · Pramand, LLC
Key facts
| Original PMA | P220014 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | CraniSeal Dural Sealant |
| Generic name | Sealant, dural |
| Applicant | Pramand, LLC |
| Product code | NQR |
| Received date | Aug 8, 2023 |
| Decision date | Dec 23, 2023 |
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: