FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Applicator, Hyperthermia, Interstitial
PMA: P880078
·
Supplement: S005
·
Decision Oct 28, 1991
Classifications
1
FEI Numbers
1
Registration Numbers
1
Basic Information
- Device Name
- Applicator, Hyperthermia, Interstitial
- Trade Name
- VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500
- PMA Number
- P880078
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- LMZ
- Generic Name
- Applicator, hyperthermia, interstitial
- Medical Specialty
- Unknown
- Advisory Committee
- Radiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 28, 1991
- Date Received
- September 19, 1990
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LMZ | Applicator, Hyperthermia, Interstitial | FDA class 3 | Unknown |