PROLIEVE THERMODILATATION SYSTEM
FDA premarket approval P030006/S014 · decided 2007-07-03
Approval details
- PMA number
- P030006
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROLIEVE THERMODILATATION SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Medifocus, Inc.
- Date received
- 2007-06-13
- Decision date
- 2007-07-03
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- APPROVAL FOR MODIFICATION OF THE USER MANUAL AS REVISION E.
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