PROLIEVE THERMODILITATION SYSTEM
FDA premarket approval P030006/S018 · decided 2008-10-16
Approval details
- PMA number
- P030006
- Supplement
- S018
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROLIEVE THERMODILITATION SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Medifocus, Inc.
- Date received
- 2008-06-05
- Decision date
- 2008-10-16
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- APPROVAL FOR THE MODIFICATIONS TO THE PORLIEVE¿ HEAT EXCHANGER CARTRIDGE ASSEMBLY METHOD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROLIEVE¿ THERMODILITATION SYSTEM AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN.
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