PMA
P820012: COSMAN ICP TELE-SENSOR(R)
FDA PMA · Monitor, intracranial pressure, implanted · Integra Lifesciences Corp.
Key facts
| PMA number | P820012 |
|---|---|
| Trade name | COSMAN ICP TELE-SENSOR(R) |
| Generic name | Monitor, intracranial pressure, implanted |
| Applicant | Integra Lifesciences Corp. |
| Owner/operator | Integra LifeSciences Corporation |
| Product code | LII |
| Approval date | Sep 2, 1982 |
| Docket number | 82M-0294 |
| Notice date | Oct 1, 1982 |
| Establishment registration | 3003418325 |
| FEI number | 3003418325 |
At a glance
- 1–9 Supplements
- Jul 29, 1999 Latest supplement decision
- Yes Withdrawn
- No 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: