PMA P030006S028
- Device
- Prolieve Thermodilation System
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S028
- Product code
- MEQ
- Decision date
- 2018-11-21
- 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 labeling update with the results of the Post Approval Study (PAS)
Current openFDA PMA Record#
- Device
- Prolieve Thermodilation System
- Applicant
- Medifocus, Inc.
- PMA number
- P030006
- Supplement
- S028
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2018-11-21
- Decision code
- APPR
- Date received
- 2018-03-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a labeling update with the results of the Post Approval Study (PAS)