PMA P030006S015
- Device
- PROLIEVE THERMODILATATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S015
- Product code
- MEQ
- Decision date
- 2007-07-10
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- SIX CHANGES: 1) REVISED WORK IN PROGRESS MANAGEMENT PROCEDURE; 2) A PROCESS DOCUMENT CHANGE; 3) CHANGE IN THE FREQUENCY OF A MAINTENANCE SCHEDULE; 4) CHANGE IN THE IDENTIFICATION OF A PART; 5) CHANGE IN THE TOLERANCE OF A PART; AND 6) CHANGE IN A SUBASSEMBLY TEST.
Current openFDA PMA Record#
- Device
- PROLIEVE THERMODILATATION SYSTEM
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S015
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2007-07-10
- Decision code
- OK30
- Date received
- 2007-06-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- SIX CHANGES: 1) REVISED WORK IN PROGRESS MANAGEMENT PROCEDURE; 2) A PROCESS DOCUMENT CHANGE; 3) CHANGE IN THE FREQUENCY OF A MAINTENANCE SCHEDULE; 4) CHANGE IN THE IDENTIFICATION OF A PART; 5) CHANGE IN THE TOLERANCE OF A PART; AND 6) CHANGE IN A SUBASSEMBLY TEST.