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U.S. Department of Health and Human Services

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes

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As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes. Links to all available summary review memos can be found here.

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Device
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Review
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Order
symbios,synergyst ipgs P820003/S132 10/19/2015 Review Approval
activitrax ii ipg,activitrax ipg,legend ii ipg,legend ipg,micro minix ipg,minix ipg,minix st ipg,premier ipg,prevail ipg P850051/S082 10/19/2015 Review Approval
medtronic gem icd,medtronic jewel icd,medtronic jewel plus icd,medtronic micro jewel icd,medtronic micro jewel ii icd,me P900061/S133 10/19/2015 Review Approval
medtronic pcd tachyarrhythmia control system P920015/S146 10/19/2015 Review Approval
legend plus ipg P930022/S017 10/19/2015 Review Approval
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