PROSTATRON PRAKTIS
FDA premarket approval P950014/S022 · decided 2004-06-10
Approval details
- PMA number
- P950014
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROSTATRON PRAKTIS
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, Inc.
- Date received
- 2004-05-17
- Decision date
- 2004-06-10
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR DESIGN CHANGES TO INCLUDE CHANGING THE CONTACTS ON THE INTERNAL WIRING FROM TIN TO GOLD AND A MODIFICATION TO THE SOFTWARE TO INCLUDE AN ADDITIONAL ALARM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROSTATRON PRAKTIS AND IS INDICATED FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH).
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