FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Rf/Microwave Hyperthermia, Cancer Treatment
PMA: P820088
·
Supplement: S005
·
Decision Sep 23, 1986
Classifications
1
FEI Numbers
1
Registration Numbers
1
Basic Information
- Device Name
- System, Rf/Microwave Hyperthermia, Cancer Treatment
- Trade Name
- BSD 1000 HYPERTHERMIA SYSTEM
- PMA Number
- P820088
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- LOC
- Generic Name
- System, rf/microwave hyperthermia, cancer treatment
- Medical Specialty
- Unknown
- Advisory Committee
- Radiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 23, 1986
- Date Received
- June 3, 1986
- 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 |
|---|---|---|---|
| LOC | System, Rf/Microwave Hyperthermia, Cancer Treatment | FDA class 3 | Unknown |