PMA
P010022: COSEAL SURGICAL SEALANT (COSEAL)
FDA PMA · Sealant, polymerizing · Angiotech Medical Device Technologies
Key facts
| PMA number | P010022 |
|---|---|
| Trade name | COSEAL SURGICAL SEALANT (COSEAL) |
| Generic name | Sealant, polymerizing |
| Applicant | Angiotech Medical Device Technologies |
| Product code | NBE |
| Approval date | Dec 14, 2001 |
| Docket number | 02M-0076 |
| Notice date | Feb 25, 2002 |
At a glance
- 1–9 Supplements
- May 6, 2003 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: