PMA P030006S017
- Device
- PROLIEVE THERMODILITATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S017
- Product code
- MEQ
- Decision date
- 2009-05-18
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR A RECTAL TEMPERATURE MONITOR WHICH IS DISPOSABLE. THE DISPOSABLE RECTAL TEMPERATURE MONITOR WILL BE CONTRACT MANUFACTURED AT PHILLIPS PLASTIC CORPORATION, SHORT-RUN FACILITY (PHILLIPS SHORT-RUN) LOCATED IN RICHMOND, WISCONSIN.
Current openFDA PMA Record#
- Device
- PROLIEVE THERMODILITATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S017
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2009-05-18
- Decision code
- APPR
- Date received
- 2008-02-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A RECTAL TEMPERATURE MONITOR WHICH IS DISPOSABLE. THE DISPOSABLE RECTAL TEMPERATURE MONITOR WILL BE CONTRACT MANUFACTURED AT PHILLIPS PLASTIC CORPORATION, SHORT-RUN FACILITY (PHILLIPS SHORT-RUN) LOCATED IN RICHMOND, WISCONSIN.