UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S029 · decided 2006-03-23
Approval details
- PMA number
- P970008
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UROLOGIX TARGIS SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2005-05-10
- Decision date
- 2006-03-23
- Days to decision
- 317 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR THE ADDITION OF A RADIO FREQUENCY IDENTIFICATION (RFID) SYSTEM TO PREVENT REUSE OF THE DISPOSABLE DEVICE COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM AND IS INDICATED FOR THE DELIVERY OF MICROWAVE ENERGY TO THE PROSTATE FOR THE TREATMENT OF BPH IN A SINGLE SESSION. IT IS INDICATED FOR PATIENTS WITH PROSTATIC LENGTHS OF 30 TO 50 MM.
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