FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
PMA: P970008
·
Supplement: S035
·
Decision Mar 7, 2008
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
- Trade Name
- UROLOGIX TARGIS SYSTEM
- PMA Number
- P970008
- Supplement Number
- S035
- Device Class
- FDA Class 3
- Product Code
- MEQ
- Generic Name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 7, 2008
- Date Received
- January 9, 2008
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR COMPONENT CHANGES TO THE MICROWAVE GENERATOR SUBASSEMBLY USED IN THE TARGIS SYSTEM CONTROL UNIT MODEL 4000 AND IN THE COOLWAVE CONTROL UNIT MODEL 5000.
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 |
|---|---|---|---|
| MEQ | System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy | FDA class 3 | Unknown |