PROLIEVE THERMODILATATION SYSTEM
FDA premarket approval P030006/S011 · decided 2006-08-10
Approval details
- PMA number
- P030006
- Supplement
- S011
- 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
- 2006-06-26
- Decision date
- 2006-08-10
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- APPROVAL FOR MANUFACTURING CHANGES TO CORRECT THE INNER MANIFOLD BOND OF THE CATHETER AND TO CONFIRM DIMENSIONS OF TUBING USED WITH THE HEAT EXCHANGER.
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