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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
Sort by PMA Number [0-9]
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Decision
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Review
Memo		 Approval
Order
kappa 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/sensia ipgs P980035/S200 05/13/2011 Review Approval
virtuoso ii/secura/maximo ii icds P980016/S273 05/13/2011 Review Approval
dema ipg/c & t series ipgs P990001/S082 05/13/2011 Review Approval
transvene cs/svc lead P980050/S057 05/13/2011 Review Approval
dual chamber, implantable pulse generator P820003/S104 05/13/2011 Review Approval
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