PMA P030006S027
- Device
- PROLIEVE THERMODILATATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S027
- Product code
- MEQ
- Decision date
- 2014-12-16
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- CHANGE TO REPLACE THE MANUAL PROCESS OF SANDING THE SURFACE PLATES OF THE HEAT EXCHANGER.
Current openFDA PMA Record#
- Device
- PROLIEVE THERMODILATATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S027
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2014-12-16
- Decision code
- OK30
- Date received
- 2014-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO REPLACE THE MANUAL PROCESS OF SANDING THE SURFACE PLATES OF THE HEAT EXCHANGER.