UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S028 · decided 2006-02-06
Approval details
- PMA number
- P970008
- Supplement
- S028
- 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
- 2005-04-28
- Decision date
- 2006-02-06
- Days to decision
- 284 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR MODIFICATION OF THE CONTROL UNIT (TARGIS "COOL WAVE" CONTROL UNIT MODEL 5000A OR NEXT GENERATION CONTROL UNIT - NGCU), SOFTWARE, AND OPERATING MODES FOR BOTH THE TARGIS MICROWAVE DELIVERY SYSTEM (MDS) AND TARGIS COOLED THERMOCATH MDS.
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