PMA
P010002: INDERMIL(TM) TISSUE ADHESIVE
FDA PMA · Tissue adhesive for the topical approximation of skin · Covidien Lp, Formerly Registered AS United States
Key facts
| PMA number | P010002 |
|---|---|
| Trade name | INDERMIL(TM) TISSUE ADHESIVE |
| Generic name | Tissue adhesive for the topical approximation of skin |
| Applicant | Covidien Lp, Formerly Registered AS United States |
| Owner/operator | Covidien llc |
| Product code | MPN |
| Approval date | May 22, 2002 |
| Docket number | 03M-0040 |
| Notice date | Feb 5, 2003 |
| Establishment registration | 1219930 |
| FEI number | 1219930 |
At a glance
- 1–9 Supplements
- Nov 12, 2003 Latest supplement decision
- No Withdrawn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: