|
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 | S026 |
Date Received | 05/21/2014 |
Decision Date | 10/24/2014 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REPLACING THE CURRENT SUPPLIER FOR MANIFOLD TUBING, AND TO REPLACE MEDICAL DEVICE ADHESIVE CURRENTLY USED IN MANUFACTURING. |