FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
PMA: P010055
·
Supplement: S009
·
Decision Jul 30, 2014
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
- Trade Name
- PROSTALUND CORETHERM SYSTEM AND PROSTALAND CORETHERM ACCESSORIES
- PMA Number
- P010055
- Supplement Number
- S009
- 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
- July 30, 2014
- Date Received
- February 21, 2014
- 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 A MANUFACTURING SITE LOCATED AT ORIFICE MEDICAL AB IN YSTAD, SWEDEN.
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 |