PROSTATRON
FDA premarket approval P950014/S009 · decided 1997-09-24
Approval details
- PMA number
- P950014
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROSTATRON
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, Inc.
- Date received
- 1997-09-18
- Decision date
- 1997-09-24
- Days to decision
- 6 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for the following changes in intended to minimize the risk of Prostaprobe balloon deflation difficulty: 1)modification of the Prostaprobe manufacturing procedures, and 2) addition of a labeling precaution.
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