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
ApplicantPROSTALUND AB
Date Received2021-06-03
Decision Date2021-06-30
PMAP010055
SupplementS011
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
S010
S009 2014-02-21 Normal 180 Day Track No User Fee
S008
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

NIH GUDID Devices

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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