PMA P030006S009
- Device
- PROLIEVE THERMODILATATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S009
- Product code
- MEQ
- Decision date
- 2006-03-15
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR MULTIPLE DESIGN MODIFICATIONS WHICH AFFECT THE SAFETY AND EFFECTIVENESS OF THE PROLIEVE DEVICE.
Current openFDA PMA Record#
- Device
- PROLIEVE THERMODILATATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S009
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2006-03-15
- Decision code
- APPR
- Date received
- 2005-11-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MULTIPLE DESIGN MODIFICATIONS WHICH AFFECT THE SAFETY AND EFFECTIVENESS OF THE PROLIEVE DEVICE.