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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
lifevest waerable defibrillator P010030/S031 11/02/2012 Review Approval
concerta, consulta/consulta df4, & various insync families of icd's; concerto ii, maximo ii,protecta,protecta xt crt-d's P010031/S329 10/26/2012 Review Approval
gem iii at P980050/S076 10/26/2012 Review Approval
entrust,secura,gem ii/iii vr/dr,intrinsic/intrinsic 30,maximo vr/dr,maximo ii,marquis vr/dr,protecta/protecta xt P980016/S376 10/26/2012 Review Approval
belos dr/dr-t/vr/vr-t, lexos dr/dr-t/vr/vr-t, lumos dr-t/vr-t, xelos dr-t icd's P000009/S049 10/03/2012 Review Approval
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