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.
1 to 50 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
natrelle silicone filled breast implants | P020056/S054 | 10/27/2021 | Approval | |
memorygel/memorygel xtra breast implants | P030053/S062 | 10/27/2021 | Approval | |
natrelle saline filled breast implants | P990074/S045 | 10/27/2021 | Approval | |
saline-filled and spectrum breast implants | P990075/S051 | 10/27/2021 | Approval | |
memoryshape breast implants | P060028/S041 | 10/27/2021 | Approval | |
sientra opus silicone gel breast implants | P070004/S033 | 10/27/2021 | Approval | |
carelink monitor, cardiosight reader, carelink express monitor | P890003/S338 | 02/01/2016 | Review | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 |
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 |
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 |
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 |
medtronic pcd tachyarrhythmia control system | P920015/S146 | 10/19/2015 | Review | Approval |
symbios,synergyst ipgs | P820003/S132 | 10/19/2015 | Review | Approval |
kappa 400 dr ipg,kappa 400 sr ipg | P970012/S096 | 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 |
legend plus ipg | P930022/S017 | 10/19/2015 | Review | Approval |
5076 capsurefix novus surescan leads | P930039/S138 | 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 | |
5086 mri capsurefix mri surescan leads | P090013/S200 | 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 | |
sensolog / dialog/ regency family of pacemakers | P880006/S093 | 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 | |
cardiomems hf pressure measurement system | P100045/S002 | 07/10/2015 | Review | |
advisa sr ipg | P980035/S424 | 06/22/2015 | Review | |
capsurefix novus mri surescan lead model 5076 | P930039/S130 | 06/22/2015 | Review | |
attain performa model 4398 and 4598 left ventricular leads | P080006/S073 | 12/10/2014 | Review |
Other Databases
- 510(k)s
- De Novo
- Medical Device Reports (MAUDE)
- CDRH Export Certificate Validation (CECV)
- CDRH FOIA Electronic Reading Room
- CFR Title 21
- CLIA
- Device Classification
- FDA Guidance Documents
- Humanitarian Device Exemption
- Medsun Reports
- Premarket Approvals (PMAs)
- Post-Approval Studies
- Postmarket Surveillance Studies
- Radiation-Emitting Products
- Radiation-Emitting Electronic Products Corrective Actions
- Recalls
- Registration & Listing
- Standards
- Total Product Life Cycle
- X-Ray Assembler
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