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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
natrelle silicone filled breast implants P020056/S054 10/27/2021   Approval
natrelle saline filled breast implants P990074/S045 10/27/2021   Approval
memorygel/memorygel xtra breast implants P030053/S062 10/27/2021   Approval
memoryshape breast implants P060028/S041 10/27/2021   Approval
saline-filled and spectrum breast implants P990075/S051 10/27/2021   Approval
sientra opus silicone gel breast implants P070004/S033 10/27/2021   Approval
attain ability mri , plus mri,straight mri surescan; attain performa mri, straight ans s mri surescan P080006/S085 02/01/2016 Review  
sprint quattro secure s mri surescan ; sprint quattro secure mri surescan P920015/S163 02/01/2016 Review  
capsurefix novus mri surescan P930039/S140 02/01/2016 Review  
capsurefix mri surescan P090013/S202 02/01/2016 Review  
carelink monitor, cardiosight reader, carelink express monitor P890003/S338 02/01/2016 Review  
restylane/restylane-l/ perlane/ perlane-l , restylane silk(injectable gels) P040024/S079 01/26/2016 Review  
iforia 7 dr-t (df-1 & df4), iperia 7 dr-t (df-1 & df-4), inventra 7 dr-t (df-1 & df-4) P050023/S087 12/21/2015 Review  
linox smart(s65)(sd65/18)(sdx65/15&65/17),protego df-1(s65)(sd65/18)(dx65/15&65/17),protego(s65&75)(sd65/16,65/18,75/18) P950037/S151 12/21/2015 Review  
programmer software(1503.u) for ics 3000/renamic programmers P000009/S063 12/21/2015 Review  
programmer software (1503.u) for the ics 3000/renamic programmers P070008/S063 12/21/2015 Review  
linox smart s65,linox smart sd 65/18,linox s dx 65/15,linox s dx 65/17,protego df-1 s 65,protego df-1 sd 65/18,protego d P980023/S072 12/21/2015 Review  
origen, inogen, and dynagen icd, incepta, energen, and punctua icd, teligen icd P960040/S360 12/21/2015 Review  
origen, inogen, and dynagen crt-d, incepta energen punctua crt-d, cognis crt-d P010012/S405 12/21/2015 Review  
evera s dr icd, evera s vr icd, evera xt dr icd, evera xt vr icd P980016/S548 10/29/2015 Review  
brava crt-d, brava quad crt-d, viva quad s crt-d, viva quad xt crt-d, viva s crt-d, viva xt crt-d P010031/S511 10/29/2015 Review  
elite,elite ii,minuet,preva,prodigy,thera d,thera dr ipgs, thera id pg,thera ipg,thera s ipg,thera sr ipg,thera vdd ipg, P890003/S326 10/19/2015 Review Approval
consulta,syncra,viva crt-ps,insync ipg P010015/S255 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
symbios,synergyst ipgs P820003/S132 10/19/2015 Review Approval
activitrax ii ipg,activitrax ipg,legend ii ipg,legend ipg,micro minix ipg,minix ipg,minix st ipg,premier ipg,prevail ipg P850051/S082 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
medtronic pcd tachyarrhythmia control system P920015/S146 10/19/2015 Review Approval
legend plus ipg P930022/S017 10/19/2015 Review Approval
kappa 400 dr ipg,kappa 400 sr ipg P970012/S096 10/19/2015 Review Approval
evera s dr icd, evera s vr icd,evera xt dr icd, evera xt vr icd,gem dr icd,gem ii dr icd, gem ii vr icd,gem iii vr icd,i P980016/S514 10/19/2015 Review Approval
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
jewel af icd P980050/S097 10/19/2015 Review Approval
vitatron c20 sr ipg,vitatron c60 dr ipg,vitatron t20 sr ipg,vitatron t60 dr ipg P990001/S119 10/19/2015 Review Approval
5076 capsurefix novus surescan leads P930039/S138 09/11/2015 Review  
5086 mri capsurefix mri surescan leads P090013/S200 09/11/2015 Review  
evera mri xt dr, xt vr, s dr, s vr surescan icd's P980016/S536 09/11/2015 Review  
sprint quattro secure s mri surescan and sprint quattro secure mri surescan P920015/S151 09/11/2015 Review  
carelink monitor and express monitor, cardiosight reader; carelink express P890003/S329 09/11/2015 Review  
ellipse/fortify assura family of icd's P910023/S355 08/27/2015 Review  
quadra assura / unify assura family of crt-d's P030054/S284 08/27/2015 Review  
frontier / frontier ii / anthem family of crt-p's P030035/S133 08/27/2015 Review  
microny family of pacemakers P970013/S064 08/27/2015 Review  
affinity/integrity / victory /zephyr accent family of pacemakers P880086/S255 08/27/2015 Review  
sensolog / dialog/ regency family of pacemakers P880006/S093 08/27/2015 Review  
cardiomems hf pressure measurement system P100045/S002 07/10/2015 Review  
capsurefix novus mri surescan lead model 5076 P930039/S130 06/22/2015 Review  
advisa sr ipg P980035/S424 06/22/2015 Review  
attain performa model 4398 and 4598 left ventricular leads P080006/S073 12/10/2014 Review  
 
 
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