PROSTATRON MAXIS
FDA premarket approval P950014/S012 · decided 1998-01-22
Approval details
- PMA number
- P950014
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROSTATRON MAXIS
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, Inc.
- Date received
- 1998-01-14
- Decision date
- 1998-01-22
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for a new trade name for the single-module configuration of the PRostatron. The device will be marketed under the trade name Prostatron Maxis and is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH).
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