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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCORETHERM SYSTEM MICROWAVE THERMOTHERAPY
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Applicant
PROSTALUND AB
scheelevagen 17
se-223 63 lund SE-22-223
PMA NumberP010055
Supplement NumberS002
Date Received09/30/2004
Decision Date11/05/2004
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT MRI MANUFACTURING AND RESEARCH INC (MRI MEDICAL), 4700 S. OVERLAND DRIVE, TUCSON, ARIZONA 85714-3430. MRI MEDICAL WILL DUPLICATE MANUFACTURE THE MODIFIED PROSTALUND FEEDBACK TREATMENT (PLFT) CATHETER.
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