PROLIEVE THERMODILATATION SYSTEM
FDA premarket approval P030006/S003 · decided 2005-03-24
Approval details
- PMA number
- P030006
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- PROLIEVE THERMODILATATION SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Medifocus, Inc.
- Date received
- 2004-10-01
- Decision date
- 2005-03-24
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- APPROVAL OF A MODIFIED POST-APPROVAL STUDY FOR THE DEVICE.
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