|
Device | PROLIEVE THERMODILITATION 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 | S017 |
Date Received | 02/12/2008 |
Decision Date | 05/18/2009 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A RECTAL TEMPERATURE MONITOR WHICH IS DISPOSABLE. THE DISPOSABLE RECTAL TEMPERATURE MONITOR WILL BE CONTRACT MANUFACTURED AT PHILLIPS PLASTIC CORPORATION, SHORT-RUN FACILITY (PHILLIPS SHORT-RUN) LOCATED IN RICHMOND, WISCONSIN. |
Post-Approval Study | Show Report Schedule and Study Progress |