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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
adapta,versa,sensia ipg,advisa dr ipg,advisa dr mri ipg,at500 dddrp pacing system ipg, enpulse e2 ipg,enpulse e2 ipg,kap P980035/S404 10/19/2015 Review Approval
medtronic gem icd,medtronic jewel icd,medtronic jewel plus icd,medtronic micro jewel icd,medtronic micro jewel ii icd,me P900061/S133 10/19/2015 Review Approval
brava,brava quad,concerto ii,consulta,maximo ii,protecta,protecta xt,viva quad s, viva quad xt,viva s, viva xt crt-ds, c P010031/S478 10/19/2015 Review Approval
revo mri ipg P090013/S165 10/19/2015 Review Approval
jewel af icd P980050/S097 10/19/2015 Review Approval
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