PMA supplement
P990028 S002: FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
FDA PMA supplement · Real-Time Process · Genzyme Corp.
Key facts
| Original PMA | P990028 |
|---|---|
| Supplement number | S002 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT |
| Generic name | Mesh, surgical, polymeric |
| Applicant | Genzyme Corp. |
| Product code | FTL |
| Received date | Jan 9, 2001 |
| Decision date | Jul 16, 2001 |
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: