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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
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Decision
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Review
Memo		 Approval
Order
reliaty/model 3145 pacing system analyzer P950037/S079 09/02/2010 Review Approval
reliaty / model 3145 family of pacing system analyzers P950037/S088 04/20/2011 Review Approval
reliance 4-site defibrillator lead P910073/S107 12/20/2012 Review Approval
radiesse injectable implant P050037/S024 10/31/2011 Review Approval
radiesse injectable implant P050052/S027 10/31/2011 Review Approval
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