UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
FDA premarket approval P970008/S055 · decided 2011-03-02
Approval details
- PMA number
- P970008
- Supplement
- S055
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2011-02-03
- Decision date
- 2011-03-02
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- REMOVE A TUBE TRIMMING STEP AND MOVE THE CONTROL UNIT KEYBOARD ASSEMBLY PROCESS IN HOUSE.
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