PROSTATRON
FDA premarket approval P950014/S006 · decided 1997-11-24
Approval details
- PMA number
- P950014
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROSTATRON
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, Inc.
- Date received
- 1997-04-07
- Decision date
- 1997-11-24
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for changes to the Prostatron(R) software program to include a high energy treatment protocol (using either the single or dual-module hardware configurations).
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