UROLOGIX TARGIS SYSTEM CONTROL UNIT
FDA premarket approval P970008/S015 · decided 2001-12-06
Approval details
- PMA number
- P970008
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UROLOGIX TARGIS SYSTEM CONTROL UNIT
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2000-11-22
- Decision date
- 2001-12-06
- Days to decision
- 379 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT COLORADO MEDTECH, LONGMONT, COLORADO.
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