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: AMPLATZER PFO OCCLUDER
• Generic Name: Transcatheter septal occluder
• Applicant: Abbott Medical; 177 County Road B East; St. Paul, MN 55117
• PMA Number: P120021
• Date Received: 11/30/2012
• Decision Date: 10/28/2016
• Product Code: MLV
• Docket Number: 16M-3653
• Notice Date: 11/01/2016
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT00465270
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the AMPLATZER PFO Occluder. The device is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 ; S013 S014 S015 S016 S017 S018 S020 S021 S022 S023 S024 S025 ; S026 S027