FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
PMA: P000043
·
Supplement: S022
·
Decision Sep 18, 2013
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
- Trade Name
- THERMATRX OFFICE THERMOTHERAPY SYSTEM
- PMA Number
- P000043
- Supplement Number
- S022
- 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
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- September 18, 2013
- Date Received
- August 23, 2013
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
CHANGE IN STERILIZATION MONITORING PROCESS, CHANGE IN THE ORDER OF LABELING, AND CHANGE IN POUCH ORIENTATION.
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 |