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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
restylane l and perlane l injectable gels P040024/S039 01/29/2010 Review Approval
epic hf crt-d system P030054/S131 01/29/2010 Review Approval
cadence family of icds P910023/S215 01/29/2010 Review Approval
paradym vr model 8250 & dr model 8550 P980049/S050 04/07/2010 Review Approval
paradym crt-d model 8750 P060027/S015 04/07/2010 Review Approval
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