PMA P820088

Device: BSD-500 HYPERTHERMIA SYSTEM
Applicant: Pyrexar Medical, Inc.
PMA number: P820088
Supplement: S017
Product code: LOC
Decision date: 2004-01-20
Generic name: System, rf/microwave hyperthermia, cancer treatment
Approval order statement: APPROVAL TO REPLACE THE GENERATOR APPROVED IN PMA P820088/S005. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME, BSD-500 HYPERTHERMIA SYSTEM AND IS INDICATED FOR TREATMENT OF SOLID MALIGNANT TUMORS BY LOCALIZED HEAT DELIVERY.

Current openFDA PMA Record#

Device: BSD-500 HYPERTHERMIA SYSTEM
Applicant: Pyrexar Medical, Inc.
PMA number: P820088
Supplement: S017
Product code: LOC
Generic name: System, rf/microwave hyperthermia, cancer treatment
Decision date: 2004-01-20
Decision code: APPR
Date received: 2003-09-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO REPLACE THE GENERATOR APPROVED IN PMA P820088/S005. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME, BSD-500 HYPERTHERMIA SYSTEM AND IS INDICATED FOR TREATMENT OF SOLID MALIGNANT TUMORS BY LOCALIZED HEAT DELIVERY.