PMA P030006S024

Device
PROLIEVE THERMODILITATION SYSTEM
Applicant
Medifocus, Inc.
PMA number
P030006
Supplement
S024
Product code
MEQ
Decision date
2011-05-13
Classification
System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
PROLIEVE THERMODILITATION SYSTEM
Applicant
Medifocus, Inc.
PMA number
P030006
Supplement
S024
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
2011-05-13
Decision code
APPR
Date received
2010-12-23
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.