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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
Number
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Review
Memo		 Approval
Order
reocor s / d family of external pacemakers P950037/S084 05/08/2012 Review Approval
reliaty / model 3145 family of pacing system analyzers P950037/S088 04/20/2011 Review Approval
implantable pacemaker pulse generator,pacemaker programming P950037/S089 04/15/2011 Review Approval
evia / entovis family of pulse generators P950037/S091 03/25/2011 Review Approval
evia/entovis/estella/effecta/ecuro P950037/S098 09/30/2011 Review Approval
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