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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
Name
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PMA
Number
Sort by PMA Number [0-9]
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Decision
Date
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Review
Memo		 Approval
Order
kronos lv-t crt-d and lumax 300/340 & 500/540 crt-d's & icd's P050023/S053 10/03/2012 Review Approval
stratos lv/lv-t P070008/S031 10/03/2012 Review Approval
various families of philos, cylos, evia, entovis, estella, ecuro, & effecta implantable pacemakers P950037/S105 10/03/2012 Review Approval
durata leads P950022/S079 09/13/2012   Approval
tendril family of leads P960013/S068 09/13/2012 Review Approval
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