PMA supplement
P010002 S004: INDERMIL TISSUE ADHESIVE
FDA PMA supplement · Real-Time Process · Covidien Lp, Formerly Registered AS United States
Key facts
| Original PMA | P010002 |
|---|---|
| Supplement number | S004 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | INDERMIL TISSUE ADHESIVE |
| Generic name | Tissue adhesive for the topical approximation of skin |
| Applicant | Covidien Lp, Formerly Registered AS United States |
| Product code | MPN |
| Received date | May 19, 2003 |
| Decision date | Nov 12, 2003 |
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: