PROSTATRON MAXIS
FDA premarket approval P950014/S013 · decided 1998-03-10
Approval details
- PMA number
- P950014
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROSTATRON MAXIS
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, Inc.
- Date received
- 1998-03-04
- Decision date
- 1998-03-10
- Days to decision
- 6 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for 1) the addition of a barcode identification label to the Prostaprobe, and 2) modifications to the Prostatron(TM) Maxis and dual module configurations to require entry of the Prostaprobe barcode information prior to treatment.
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