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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.
 
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-223
PMA NumberP010055
Supplement NumberS011
Date Received06/03/2021
Decision Date06/30/2021
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Manufacturing change to move facilities including relocating critical analytical equipment.
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