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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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PMA
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Review
Memo
Approval
Order
entrust icd family P980035/S166 10/19/2010 Review Approval
carelink ddma software and carelink monitor P890003/S191 10/19/2010 Review Approval
endotak reliance 4-site leads and accessories P910073/S077 11/10/2010 Review Approval
lead tunneler model 6888 P830060/S062 11/10/2010 Review Approval
teligen 4-site models P960040/S198 11/10/2010 Review Approval
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