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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantPROSTALUND AB
SCHEELEVAGEN 17
SE-223 63 LUND SE-22-223
PMA NumberP010055
Date Received09/10/2001
Decision Date12/23/2002
Product Code MEQ 
Docket Number 03M-0189
Notice Date 05/09/2003
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE PROSTALUND CORETHERM MICROWAVE THERMOTHERAPY SYSTEM. THE PROSTALUND CORETHERM IS A NON-SURGICAL, MINIMALLY INVASIVE DEVICE INTENDED TO RELIEVE SYMPTOMS ASSOCIATED WITH SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) BYE PROSTALUND FEEDBACK TREATMENT (PLFT), AND IS INDICATED FOR MEN WITH PROSTATE SIZE OF 30 TO 100G AND PROSTATIC URETHRA LENGTH >= 35 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S009 S011 
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