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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
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Review
Memo		 Approval
Order
vistatron c&t series (model vsf04 v8.0, model vsf 12 v8.0, model vsf08 v8.0) P990001/S105 03/13/2013 Review Approval
cardiac resynchronization therapy-pacemaker (crt-p) models v172 and v173 P030005/S088 03/12/2013 Review Approval
cameron health subcutaneous implantable defibrillator s-icd system P110042/S002 03/07/2013 Review Approval
linox(smart) s dx steroid-eluting single-coil icd leads P980023/S049 02/13/2013 Review Approval
model 5019 high voltage (hv) splitter/adaptor kit P920015/S093 02/13/2013 Review Approval
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