PMA P970008S017
- Device
- TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S017
- Product code
- MEQ
- Decision date
- 2001-06-05
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order 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.
Current openFDA PMA Record#
- Device
- TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S017
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2001-06-05
- Decision code
- APPR
- Date received
- 2001-05-24
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.