PROLIEVE THERMODILATATION SYSTEM
FDA premarket approval P030006/S010 · decided 2006-01-20
Approval details
- PMA number
- P030006
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROLIEVE THERMODILATATION SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Medifocus, Inc.
- Date received
- 2005-12-01
- Decision date
- 2006-01-20
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- APPROVAL FOR A NEW SANMINA-SCI CORPORATION MANUFACTURING SITE LOCATED IN HUNTSVILLE, ALABAMA TO MANUFACTURE THE PROLIEVE THERMODILATATION SYSTEM CONSOLE AND RECTAL TEMPERATURE MONITOR.
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