UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S030 · decided 2006-03-20
Approval details
- PMA number
- P970008
- Supplement
- S030
- 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
- 2005-11-21
- Decision date
- 2006-03-20
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR UPGRADES TO THE TARGIS SYSTEM. THESE CHANGES INCLUDE IMPROVED APPEARANCE (WHICH REQUIRED REPLACING THE CONTROL UNIT EXTERIOR PANELS AND MOVING THE USER CONTROLS), IMPROVED ELECTROMAGNETIC COMPATIBILITY (EMC), AND OTHER COMPONENT AND MANUFACTURING MODIFICATIONS DUE TO COMPONENT OBSOLESCENCE.
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