|
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 | S004 |
Date Received | 01/28/2005 |
Decision Date | 03/11/2005 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A NEW INK TO BE USED TO MARK THE CATHETER COMPONENT OF THE DEVICE USING THE SAME PAD PRINTING PROCESS FOR APPLYING THESE MARKINGS. |
Post-Approval Study | Show Report Schedule and Study Progress |