- Device
- PROLIEVE THERMODILATATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S004
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2005-03-11
- Decision code
- APPR
- Date received
- 2005-01-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW INK TO BE USED TO MARK THE CATHETER COMPONENT OF THE DEVICE USING THE SAME PAD PRINTING PROCESS FOR APPLYING THESE MARKINGS.