PMA supplement
P880078 S006: VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500
FDA PMA supplement · Normal 180 Day Track · Cook, Inc.
Key facts
| Original PMA | P880078 |
|---|---|
| Supplement number | S006 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500 |
| Generic name | Applicator, hyperthermia, interstitial |
| Applicant | Cook, Inc. |
| Product code | LMZ |
| Received date | Dec 13, 1991 |
| Decision date | Feb 25, 1992 |
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: