UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S043 · decided 2009-03-05
Approval details
- PMA number
- P970008
- Supplement
- S043
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UROLOGIX TARGIS SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2009-02-03
- Decision date
- 2009-03-05
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- CHANGES TO THE ETHYLENE OXIDE STERILIZATION PROCESS USED ON THE TARGIS SYSTEM COMPONENTS.
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