UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
FDA premarket approval P970008/S026 · decided 2005-06-16
Approval details
- PMA number
- P970008
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2005-02-25
- Decision date
- 2005-06-16
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR A LONGER VERSION OF THE COOLED THERMOCATH MICROWAVE DELIVERY CATHETER. THE LONGER ANTENNA IS 37 MM COMPARED TO THE 28 MM ANTENNA IN THE CURRENTLY APPROVED COOLED THERMOCATH CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COOLED THERMOCATH 4.5+ AND IS INDICATED FOR MEN WITH PROSTATIC URETHRAL LENGTHS OF 4.5 CM OR GREATER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.