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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
Date
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Review
Memo
Approval
Order
kappa 400 dr/sr ipgs P970012/S081 05/13/2011 Review Approval
virtuoso ii/secura/maximo ii icds P980016/S273 05/13/2011 Review Approval
concerto ii/maximo ii/consulta crt-ds P010031/S228 05/13/2011 Review Approval
legend plus family of pacemakers P930022/S012 05/13/2011 Review Approval
kappa 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/sensia ipgs P980035/S200 05/13/2011 Review Approval
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