UROLOGIC TARGIS SYSTEM
FDA premarket approval P970008/S007 · decided 1998-07-07
Approval details
- PMA number
- P970008
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UROLOGIC TARGIS SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 1998-06-30
- Decision date
- 1998-07-07
- Days to decision
- 7 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for the Targis(TM) Patient Comfort Kit which includes the MDS Holder and Knee Cusions.
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