Premarket Approval (PMA)

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.

• Device: Implantable System for Remodulin
• Generic Name: Pump, infusion, implanted, programmable
• Applicant: Medtronic, Inc.; 710 MEDTRONIC PARKWAY NE; MINNEAPOLIS, MN 55432-5604
• PMA Number: P140032
• Date Received: 12/23/2014
• Decision Date: 12/22/2017
• Withdrawal Date: 08/18/2021
• Product Code: LKK
• Docket Number: 17M-6984
• Notice Date: 01/09/2018
• Advisory Committee: General Hospital
• Clinical Trials: NCT01321073
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show 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