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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
latitude wave communicator (model 6498) P910077/S119 01/28/2013 Review Approval
reliance 4-site defibrillator lead P910073/S107 12/20/2012 Review Approval
merlin home 6.1m P910023/S307 12/19/2012 Review Approval
merlin net 6.1m P030054/S237 12/19/2012 Review Approval
accent, identity, identity adx, integrity adx, verity adx, victory, zepher, microny pacemakers P880086/S202 12/04/2012 Review Approval
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