PMA
P990028: FOCAL SEAL-L SYNTHETIC ABSORBABLE SEALANT
FDA PMA · Sealant, polymerizing · Genzyme Corp.
Key facts
| PMA number | P990028 |
|---|---|
| Trade name | FOCAL SEAL-L SYNTHETIC ABSORBABLE SEALANT |
| Generic name | Sealant, polymerizing |
| Applicant | Genzyme Corp. |
| Owner/operator | GENZYME CORPORATION |
| Product code | NBE |
| Approval date | May 26, 2000 |
| Docket number | 00M-1507 |
| Notice date | Sep 11, 2000 |
| Establishment registration | 1220423 |
| FEI number | 1220423 |
At a glance
- 1–9 Supplements
- Dec 4, 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- Yes Withdrawn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: