|
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 | S020 |
Date Received | 11/14/2008 |
Decision Date | 12/09/2008 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement ADDITION OF AN ADHESIVE IN THE MANUFACTURING OF THE RECTAL TEMPERATURE MONITOR. |
Post-Approval Study | Show Report Schedule and Study Progress |