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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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PMA
Number
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Decision
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Review
Memo		 Approval
Order
tendril family of leads P960013/S068 09/13/2012 Review Approval
teligen, incepta, energen and punctua icd devices P960040/S270 11/30/2012 Review Approval
teligen 4-site models P960040/S198 11/10/2010 Review Approval
synergyst ii pacing system P890003/S265 05/30/2013 Review Approval
symbios,synergyst ipgs P820003/S132 10/19/2015 Review Approval
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