FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
PMA: P950014
·
Supplement: S014
·
Decision Jun 9, 1998
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
- Trade Name
- PROSTATRON
- PMA Number
- P950014
- Supplement Number
- S014
- 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
- June 9, 1998
- Date Received
- June 9, 1998
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for an upgrade to the Prostatron's (TM) operating software to Prostasoft 4.0 (aslo referred to as "Prostasoft 98").
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 |