PMA P030006S003
- Device
- PROLIEVE THERMODILATATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S003
- Product code
- MEQ
- Decision date
- 2005-03-24
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL OF A MODIFIED POST-APPROVAL STUDY FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- PROLIEVE THERMODILATATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S003
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2005-03-24
- Decision code
- APPR
- Date received
- 2004-10-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL OF A MODIFIED POST-APPROVAL STUDY FOR THE DEVICE.