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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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Review
Memo		 Approval
Order
sprint quattro secure s mri surescan ; sprint quattro secure mri surescan P920015/S163 02/01/2016 Review  
spectranetics laser sheath device P960042/S031 04/20/2012 Review Approval
spectranetics laser sheath P960042/S043 06/14/2013 Review Approval
sientra opus silicone gel breast implants P070004/S033 10/27/2021   Approval
sensolog/dialog/regency family of pacemakers P880006/S084 06/06/2013 Review Approval
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