PROSTATRON
FDA premarket approval P950014/S004 · decided 1996-10-29
Approval details
- PMA number
- P950014
- Supplement
- S004
- 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
- 1996-10-25
- Decision date
- 1996-10-29
- Days to decision
- 4 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- UPGRADES IN 1)THE LUXTRON THERMOMETRY UNIT FROM MODEL 3000-4 TO MODEL 3100; 2) THE COMPUTER PROCESSOR FROM 386 TO PENTIUM; AND 3) THE SOFTWARE FROM VERSION 3.07 TO VERSION 3.09
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