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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
Memo		 Approval
Order
vigila and volta and passive fixation bipolar steroid eluting icd leads P980023/S046 02/22/2012 Review Approval
cellpaker plasma collection device P050044/S019 01/31/2012 Review Approval
carelink home monitor model 2490c, cardiosight reader model 2020a, caelink network device P890003/S179 01/09/2012 Review Approval
medtronic consulta crt-d d204trm, maximo ii crt-d d264trm implantable cardioverter defibrillators P010031/S176 01/09/2012 Review Approval
medtronic sprint quattro secure lead model 6947m P920015/S055 01/09/2012 Review Approval
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