PROSTATRON
FDA premarket approval P950014/S018 · decided 1999-05-19
Approval details
- PMA number
- P950014
- Supplement
- S018
- Supplement type
- Real-Time Process
- 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
- 1999-05-17
- Decision date
- 1999-05-19
- Days to decision
- 2 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for upgrades to the Prostasoft software to version 4.02.
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