|
Device | PROLIEVE THERMODILATATION SYSTEM |
Generic Name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
Applicant | MEDIFOCUS, INC 10240 OLD COLUMBIA ROAD SUITE G COLUMBIA, MD 21046 |
PMA Number | P030006 |
Supplement Number | S013 |
Date Received | 04/23/2007 |
Decision Date | 11/20/2007 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY. |