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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.
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
scheelevagen 17
se-223 63 lund SE-22-223
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S009