FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
PMA: P000043
·
Supplement: S008
·
Decision Dec 22, 2003
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
- Trade Name
- TMX-2000 BPH THERMOTHERAPY SYSTEM
- PMA Number
- P000043
- Supplement Number
- S008
- 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
- December 22, 2003
- Date Received
- November 21, 2003
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THERMATRX, INC., NORTHBROOK, ILLINOIS AS AN ALTERNATE MANUFACTURING SITE FOR THE TEMPERATURE SENSOR AND TEMPERATURE REFERENCE PROBE.
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 |