Approval for a manufacturing site located at cenova innovation and production ab in mjolby, sweden, where catheter packaging will be performed.
| Device | CORETHERM SYSTEM MICROWAVE THERMOTHERAPY |
| 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 | 2009-04-02 |
| Decision Date | 2009-06-08 |
| PMA | P010055 |
| Supplement | S006 |
| Product Code | MEQ |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location 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