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Trade Name | BSD-2000 HYPERTHERMIA SYSTEM |
Classification Name | rf/microwave hyperthermia system, cancer treatment |
Generic Name | rf/microwave hyperthermia system, cancer treatment |
Applicant |
PYREXAR MEDICAL INC |
1825 west research way |
suite e |
salt lake city, UT 84119 |
|
HDE Number | H090002 |
Date Received | 05/26/2009 |
Decision Date | 11/18/2011 |
Product Code | |
Docket Number | 11M-0848 |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | hde original |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the bsd-2000 hyperthermia system. This device is indicated for use in conjunction with radiation therapy for thetreatment of cervical carcinoma patients who normally would be treated with combined chemotherapyand radiation but are ineligible for chemotherapy due to patient related factors. |
Approval Order | Approval Order |
Summary | Summary of Safety And Probable Benefit |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 |