|
Device | CORETHERM SYSTEM MICROWAVE THERMOTHERAPY |
Generic Name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
Applicant | PROSTALUND AB SCHEELEVAGEN 17 SE-223 63 LUND SE-22-223 |
PMA Number | P010055 |
Supplement Number | S006 |
Date Received | 04/02/2009 |
Decision Date | 06/08/2009 |
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 Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT CENOVA INNOVATION AND PRODUCTION AB IN MJOLBY, SWEDEN, WHERE CATHETER PACKAGING WILL BE PERFORMED. |