Approval for the prostalund coretherm microwave thermotherapy system. The prostalund coretherm is a non-surgical, minimally invasive device intended to relieve symptoms associated with symptomatic benign prostatic hyperplasia (bph) bye prostalund feedback treatment (plft), and is indicated for men with prostate size of 30 to 100g and prostatic urethra length >= 35 mm.
| Device | PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH |
| Classification Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Generic Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Applicant | PROSTALUND AB |
| Date Received | 2001-09-10 |
| Decision Date | 2002-12-23 |
| Notice Date | 2003-05-09 |
| PMA | P010055 |
| Supplement | S |
| Product Code | MEQ |
| Docket Number | 03M-0189 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PROSTALUND AB scheelevagen 17 se-223 63 Lund SE-22-223 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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