|
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 | S015 |
Date Received | 06/14/2007 |
Decision Date | 07/10/2007 |
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 |
Approval Order Statement SIX CHANGES: 1) REVISED WORK IN PROGRESS MANAGEMENT PROCEDURE; 2) A PROCESS DOCUMENT CHANGE; 3) CHANGE IN THE FREQUENCY OF A MAINTENANCE SCHEDULE; 4) CHANGE IN THE IDENTIFICATION OF A PART; 5) CHANGE IN THE TOLERANCE OF A PART; AND 6) CHANGE IN A SUBASSEMBLY TEST. |