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

• Device: ProstaLund CoreTherm System Microwave Thermotherapy for BPH
• Generic Name: System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
• Applicant: PROSTALUND AB
• Date Received: 2021-06-03
• Decision Date: 2021-06-30
• PMA: P010055
• Supplement: S011
• Product Code: MEQ
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: PROSTALUND AB scheelevagen 17 se-223 63 Lund SE-22-223

Supplemental Filings

Supplement Number	Date	Supplement Type
P010055		Original 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 ID	PMA	Supp
07350081910082	P010055	009
07350081910075	P010055	009
07350081910068	P010055	009
07350081910051	P010055	009
07350081910044	P010055	009
07350081910037	P010055	009
07350081910020	P010055	009
07350081910013	P010055	009