PMA P950014S012
- Device
- PROSTATRON MAXIS
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S012
- Product code
- MEQ
- Decision date
- 1998-01-22
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order 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).
Current openFDA PMA Record#
- Device
- PROSTATRON MAXIS
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S012
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 1998-01-22
- Decision code
- APPR
- Date received
- 1998-01-14
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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).