ProstaLund CoreTherm System Microwave Thermotherapy for BPH

FDA Premarket Approval P010055 S011

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.

Pre-market Approval Supplement Details

A manufacturing change to move facilities including relocating critical analytical equipment

DeviceProstaLund CoreTherm System Microwave Thermotherapy for BPH
Generic NameSystem, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Date Received2021-06-03
Decision Date2021-06-30
Product CodeMEQ 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address PROSTALUND AB scheelevagen 17 se-223 63 Lund SE-22-223

Supplemental Filings

Supplement NumberDateSupplement Type
P010055Original Filing
S011 2021-06-03 30-day Notice
S009 2014-02-21 Normal 180 Day Track No User Fee
S007 2009-09-09 Normal 180 Day Track
S006 2009-04-02 Normal 180 Day Track No User Fee
S005 2009-04-02 Normal 180 Day Track No User Fee
S004 2007-05-25 30-day Notice
S003 2006-11-22 30-day Notice
S002 2004-09-30 Normal 180 Day Track No User Fee
S001 2004-07-30 Normal 180 Day Track


Device IDPMASupp
07350081910082 P010055 009
07350081910075 P010055 009
07350081910068 P010055 009
07350081910051 P010055 009
07350081910044 P010055 009
07350081910037 P010055 009
07350081910020 P010055 009
07350081910013 P010055 009

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