PROSTATRON
FDA premarket approval P950014/S010 · decided 1997-10-07
Approval details
- PMA number
- P950014
- Supplement
- S010
- 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
- 1997-10-01
- Decision date
- 1997-10-07
- Days to decision
- 6 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for a transmobile version fothe Prostatron (dual module version).
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