TARGIS SYSTEM
FDA premarket approval P970008/S017 · decided 2001-06-05
Approval details
- PMA number
- P970008
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TARGIS SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2001-05-24
- Decision date
- 2001-06-05
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL TO REVISE THE LABELING TO 1) ADD PRIOR PELVIC RADIATION AS A CONTRINDICATION; AND 2) UPDATE THE LIST OF POTENTIAL ADVERSE EVENTS TO INCLUDE THE RISK OF RECTAL FISTULA.
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