UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S019 · decided 2002-08-01
Approval details
- PMA number
- P970008
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- UROLOGIX TARGIS SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2002-02-04
- Decision date
- 2002-08-01
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR MODIFICATION OF THE TARGIS SYSTEM LABELING REGARDING THE TREATMENT OF PATIENTS WITH IMPLANTED ACTIVE DEVICES (INCLUDING PACEMAKERS AND DEFIBRILLATORS).
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