PROLIEVE THERMODILITATION SYSTEM
FDA premarket approval P030006/S024 · decided 2011-05-13
Approval details
- PMA number
- P030006
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- PROLIEVE THERMODILITATION SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Medifocus, Inc.
- Date received
- 2010-12-23
- Decision date
- 2011-05-13
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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