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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NamePROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave/thermal therapy system
ApplicantPROSTALUND AB
PMA NumberP010055
Date Received09/10/2001
Decision Date12/23/2002
Product Code
MEQ[ Registered Establishments with MEQ ]
Docket Number 03M-0189
Notice Date 05/09/2003
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 
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