PMA supplement
P030039 S023: Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator
FDA PMA supplement · Real-Time Process · Baxter Bio Science
Key facts
| Original PMA | P030039 |
|---|---|
| Supplement number | S023 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator |
| Generic name | Sealant, polymerizing |
| Applicant | Baxter Bio Science |
| Product code | NBE |
| Received date | May 3, 2018 |
| Decision date | Jul 26, 2018 |
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: