Prolieve Thermodilation System
FDA premarket approval P030006/S028 · decided 2018-11-21
Approval details
- PMA number
- P030006
- Supplement
- S028
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Prolieve Thermodilation System
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Medifocus, Inc.
- Date received
- 2018-03-30
- Decision date
- 2018-11-21
- Days to decision
- 236 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- Approval for a labeling update with the results of the Post Approval Study (PAS)
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