Approval for modification of the indications for use and associated modifications to the catheter, antenna, and temperature probe for patients with prostates smaller than currently indicated. The device, as modified, will be marketed under the trade name corethermaccessories for small prostates and is indicated for use together with prostalund coretherm /se in patients with glands size 20-50g and with a prostate length ¿25 mm.
| Device | PROSTALUND CORETHERM SYSTEM |
| 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 | 2009-09-09 |
| Decision Date | 2014-01-29 |
| PMA | P010055 |
| Supplement | S007 |
| Product Code | MEQ |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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