PMA P950014S021
- Device
- PROSTATRON (TM) SYSTEM DISPOSABLE TREATMENT APPLICATOR
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S021
- Product code
- MEQ
- Decision date
- 2001-09-19
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT VENUSA DE MEXICO S.A. DE C.V, CHIHUAHUA, MEXICO, IN WHICH THE PROSTATRON DISPOSABLE TREATMENT APPLICATOR WILL BE ASSEMBLED. IN ADDITION, APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT VENUSA LTD., EL PASO, TEXAS, FOR THE RECEIPT, INSPECTION, STORAGE, AND RELEASE OF COMPONENTS AND THE QUARANTINE OF FINISHED STERILIZED DEVICES. ALSO, THE APPLICATOR WILL BE STERILIZED AT GRIFFITH MICROSCIENCE, SANTA TERESA, NEW MEXICO.
Current openFDA PMA Record#
- Device
- PROSTATRON (TM) SYSTEM DISPOSABLE TREATMENT APPLICATOR
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S021
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2001-09-19
- Decision code
- APPR
- Date received
- 2001-07-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT VENUSA DE MEXICO S.A. DE C.V, CHIHUAHUA, MEXICO, IN WHICH THE PROSTATRON DISPOSABLE TREATMENT APPLICATOR WILL BE ASSEMBLED. IN ADDITION, APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT VENUSA LTD., EL PASO, TEXAS, FOR THE RECEIPT, INSPECTION, STORAGE, AND RELEASE OF COMPONENTS AND THE QUARANTINE OF FINISHED STERILIZED DEVICES. ALSO, THE APPLICATOR WILL BE STERILIZED AT GRIFFITH MICROSCIENCE, SANTA TERESA, NEW MEXICO.