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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceImplantable System for Remodulin
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
710 MEDTRONIC PARKWAY NE
MINNEAPOLIS, MN 55432-5604
PMA NumberP140032
Date Received12/23/2014
Decision Date12/22/2017
Withdrawal Date08/18/2021
Product Code LKK 
Docket Number 17M-6984
Notice Date 01/09/2018
Advisory Committee General Hospital
Clinical TrialsNCT01321073
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Implantable System for Remodulin®. This device is indicated for adult patients with Class I, II and III pulmonary arterial hypertension (PAH) receiving intravenous delivery of Remodulin.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S012 S013 S014 S036 S037 S038  S027 S028 S029 S030 S049 
S064 S065 S031 S072 S073 S068 S069 S070 S004 S005 S006 S007 
S008 S009 S010 S011 S001 S002 S015 S016 S017 S003 S055 S056 
S057 S032 S033 S034 S023 S025 S026 S039 S040 S041 S042 S058 
S059 S060 S062 S063 S050 S051 S052 S053 S054 S035 S061 S043 
S044 S045 S046 S047 S048 S018 S019 S020 S021 S022 S067 S071 
S074 
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