PROLIEVE THERMODILATATION SYSTEM
FDA premarket approval P030006/S009 · decided 2006-03-15
Approval details
- PMA number
- P030006
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- 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
- 2005-11-21
- Decision date
- 2006-03-15
- Days to decision
- 114 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- APPROVAL FOR MULTIPLE DESIGN MODIFICATIONS WHICH AFFECT THE SAFETY AND EFFECTIVENESS OF THE PROLIEVE DEVICE.
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