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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
medtronic secura dr d204drm, maximo ii d264drm, implantable cardioverter defibrillators P980016/S216 01/09/2012 Review Approval
endotak reliance is-i passive fixation P910073/S091 01/05/2012 Review Approval
cardiac resynchronization therapy defibrillator (crt-d) P030054/S173 11/29/2011 Review Approval
model 4195 attain starfix lead P060039/S021 11/22/2011 Review Approval
lumax 500/540 icds thoracic impedance P050023/S047 11/17/2011 Review Approval
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