PMA P030006S016
- Device
- PROLIEVE THERMODILITATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S016
- Product code
- MEQ
- Decision date
- 2007-10-24
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- CHANGES INTENDED TO REDUCE IN-PROCESS SCRAP OF THE CATHETER COMPONENT.
Current openFDA PMA Record#
- Device
- PROLIEVE THERMODILITATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S016
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2007-10-24
- Decision code
- OK30
- Date received
- 2007-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES INTENDED TO REDUCE IN-PROCESS SCRAP OF THE CATHETER COMPONENT.