PROLIEVE THERMODILATATION SYSTEM
FDA premarket approval P030006/S004 · decided 2005-03-11
Approval details
- PMA number
- P030006
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROLIEVE THERMODILATATION SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Medifocus, Inc.
- Date received
- 2005-01-28
- Decision date
- 2005-03-11
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- APPROVAL FOR A NEW INK TO BE USED TO MARK THE CATHETER COMPONENT OF THE DEVICE USING THE SAME PAD PRINTING PROCESS FOR APPLYING THESE MARKINGS.
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