Approval for technological modifications to the coretherm system to comply with the new edition of iec 6061-1-2 "medical electrical equipment - part1: general requirements for safety; electromagnetic compatibility requirements and tests" (2nd edition, 2001).
| 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 | 2004-07-30 |
| Decision Date | 2005-07-07 |
| PMA | P010055 |
| Supplement | S001 |
| 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