PMA P970008S020
- Device
- UROLOGIX TARGIS SYSTEM FOR TREATMENT OF BPH
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S020
- Product code
- MEQ
- Decision date
- 2002-04-10
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR CHANGES TO THE "CONTRAINDICATIONS" AND PRECAUTIONS" SECTIONS OF THE LABELING.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM FOR TREATMENT OF BPH
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S020
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2002-04-10
- Decision code
- APPR
- Date received
- 2002-03-29
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE "CONTRAINDICATIONS" AND PRECAUTIONS" SECTIONS OF THE LABELING.