UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S060 · decided 2012-02-03
Approval details
- PMA number
- P970008
- Supplement
- S060
- Supplement type
- Real-Time Process
- 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
- 2011-12-20
- Decision date
- 2012-02-03
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR MINOR CHANGES TO THE SOFTWARE FOR THE TARGIS SYSTEM COOLWAVE CONTROL UNIT MODEL 5000 AND ASSOCIATED CHANGES TO THE USER MANUAL. THE DEVICE,AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM AND IS INDICATED FOR THE RELIEF OF SYMPTOMS AND OBSTRUCTIONS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA (BPH) FOR MEN WITH PROSTATIC URETHRAL LENGTHS OF 2.5-3.5CM (SHORT ANTENNA), OR 3.0-5.0CM (STANDARD ANTENNA), OR 4.5+CM (LONG ANTENNA).
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