PROSTATRON
FDA premarket approval P950014/S016 · decided 1998-10-14
Approval details
- PMA number
- P950014
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- 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
- 1998-06-25
- Decision date
- 1998-10-14
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for modifications to the Prostatron's(R) labeling which summarize the results of the postapproval study.
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