PROLIEVE THERMODILITATION SYSTEM
FDA premarket approval P030006/S021 · decided 2009-06-19
Approval details
- PMA number
- P030006
- Supplement
- S021
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROLIEVE THERMODILITATION SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Medifocus, Inc.
- Date received
- 2009-01-16
- Decision date
- 2009-06-19
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- APPROVAL FOR MODIFICATION TO THE WELDING PROCESS THAT IS USED TO BOND THE CATHETER TIP TO THE CATHETER EXTRUSION FOR THE PROLIEVE TREATMENT CATHETER.
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