PROSTATRON
FDA premarket approval P950014/S014 · decided 1998-06-09
Approval details
- PMA number
- P950014
- Supplement
- S014
- 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
- 1998-06-09
- Decision date
- 1998-06-09
- Days to decision
- 0 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for an upgrade to the Prostatron's (TM) operating software to Prostasoft 4.0 (aslo referred to as "Prostasoft 98").
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