TARGIS SYSTEM
FDA premarket approval P970008/S033 · decided 2008-04-15
Approval details
- PMA number
- P970008
- Supplement
- S033
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TARGIS SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2007-07-11
- Decision date
- 2008-04-15
- Days to decision
- 279 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 MEDTECH COSTA RICA, SA, COSTA RICA, CENTRAL AMERICA FOR THE MANUFACTURING OF THE COOLANT BAG KITS.
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