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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
Name
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PMA
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Review
Memo
Approval
Order
medtronic pcd tachyarrhythmia control system P920015/S146 10/19/2015 Review Approval
symbios,synergyst ipgs P820003/S132 10/19/2015 Review Approval
kappa 400 dr ipg,kappa 400 sr ipg P970012/S096 10/19/2015 Review Approval
vitatron c20 sr ipg,vitatron c60 dr ipg,vitatron t20 sr ipg,vitatron t60 dr ipg P990001/S119 10/19/2015 Review Approval
legend plus ipg P930022/S017 10/19/2015 Review Approval
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