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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
entrust icd family P980035/S166 10/19/2010 Review Approval
linox smart steroid-eluting dual-coil icd leads P980023/S038 09/17/2010 Review Approval
paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 P060027/S026 09/09/2010 Review Approval
paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 P980049/S059 09/09/2010 Review Approval
reliaty/model 3145 pacing system analyzer P950037/S079 09/02/2010 Review Approval
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