PMA supplement
P820012 S001: ICP TELE-MONITOR & ICP TELE-SENSOR
FDA PMA supplement · Integra Lifesciences Corp.
Key facts
| Original PMA | P820012 |
|---|---|
| Supplement number | S001 |
| Trade name | ICP TELE-MONITOR & ICP TELE-SENSOR |
| Generic name | Monitor, intracranial pressure, implanted |
| Applicant | Integra Lifesciences Corp. |
| Product code | LII |
| Received date | Oct 4, 1982 |
| Decision date | Nov 8, 1982 |
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: