FDA Devices Premarket Approval Summary Review Memos

$179 / year

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes includes 180-day supplements which are requested for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report

Complexity

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes dataset is published as part of a pilot program under the Center for Devices and Radiological Health (CDRH) Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes.

For each device with a 180-day supplement application listed in FDA Devices Premarket Approval Summary Review Memos dataset links of review memo and approval order.

Date Created

2013

Last Modified

2019-11-25

Version

2019-11-25

Update Frequency

Quarterly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

Open for commercial use

Source Citation

N/A

Keywords

PMA, Medical Device Design, MD Changes, MD Review, Premarket Approval, Premarket Approval Summary

Other Titles

Premarket Approval Summary Review Memos for Design Changes, Premarket Approval Summary Review Memos

NameDescriptionTypeConstraints
Device_NameMedical Device Namestringrequired : 1
PMA_NumberPremarket Approval Numberstringrequired : 1
Decision_DateThe Medical Device Approval Datedaterequired : 1
Review_MemoReview memo document's Linkstringrequired : 1
Approval_OrderApproval order document's Linkstringrequired : 1
Device NamePMA NumberDecision DateReview MemoApproval Order
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/S3262015-10-19ReviewApproval
Consulta,Syncra,Viva Crt-Ps,Insync IpgP010015/S2552015-10-19ReviewApproval
Brava,Brava Quad,Concerto Ii,Consulta,Maximo Ii,Protecta,Protecta Xt,Viva Quad S, Viva Quad Xt,Viva S, Viva Xt Crt-Ds, CP010031/S4782015-10-19ReviewApproval
Revo Mri IpgP090013/S1652015-10-19ReviewApproval
Symbios,Synergyst IpgsP820003/S1322015-10-19ReviewApproval
Activitrax Ii Ipg,Activitrax Ipg,Legend Ii Ipg,Legend Ipg,Micro Minix Ipg,Minix Ipg,Minix St Ipg,Premier Ipg,Prevail IpgP850051/S0822015-10-19ReviewApproval
Medtronic Gem Icd,Medtronic Jewel Icd,Medtronic Jewel Plus Icd,Medtronic Micro Jewel Icd,Medtronic Micro Jewel Ii Icd,MeP900061/S1332015-10-19ReviewApproval
Medtronic Pcd Tachyarrhythmia Control SystemP920015/S1462015-10-19ReviewApproval
Legend Plus IpgP930022/S0172015-10-19ReviewApproval
Kappa 400 Dr Ipg,Kappa 400 Sr IpgP970012/S0962015-10-19ReviewApproval