PMA P030006S014
- Device
- PROLIEVE THERMODILATATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S014
- Product code
- MEQ
- Decision date
- 2007-07-03
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR MODIFICATION OF THE USER MANUAL AS REVISION E.
Current openFDA PMA Record#
- Device
- PROLIEVE THERMODILATATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S014
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2007-07-03
- Decision code
- APPR
- Date received
- 2007-06-13
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATION OF THE USER MANUAL AS REVISION E.