|
Device | Prolieve Thermodilation 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 | S028 |
Date Received | 03/30/2018 |
Decision Date | 11/21/2018 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a labeling update with the results of the Post Approval Study (PAS) |