PMA
P880078: VH8500 HYPERTHERMIA TREATMENT SYSTEM
FDA PMA · Applicator, hyperthermia, interstitial · Cook, Inc.
Key facts
| PMA number | P880078 |
|---|---|
| Trade name | VH8500 HYPERTHERMIA TREATMENT SYSTEM |
| Generic name | Applicator, hyperthermia, interstitial |
| Applicant | Cook, Inc. |
| Owner/operator | COOK, INC. |
| Product code | LMZ |
| Approval date | Oct 17, 1989 |
| Docket number | 89M-0461 |
| Notice date | Nov 17, 1989 |
| Establishment registration | 1820334 |
| FEI number | 1820334 |
At a glance
- 10–99 Supplements
- Jan 26, 1994 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- Yes Withdrawn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: