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

2020-04-13

Version

2020-04-13

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 Linkstring-
Approval_OrderApproval order document's Linkstring-
Device NamePMA NumberDecision DateReview MemoApproval Order
Apligraf (Graftskin)P950032/S0162000-06-20Approval
Integrity Afx Dr Model 5346 Dual Chamber Pulse Generator And Programmer Software Model 3307, V2.2aP880086/S0832001-07-11Approval
Home Monitoring SystemP950037/S0192001-10-11Approval
Juvederm Ultra Xc And Juvederm Ultra Plus XcP050047/S0052010-01-07ReviewApproval
Floseal Hemostatic Matrix 5 Ml/10 Ml KitP990009/S0252010-01-07ReviewApproval
Cadence Family Of IcdsP910023/S2152010-01-29ReviewApproval
Epic Hf Crt-D SystemP030054/S1312010-01-29ReviewApproval
Restylane L And Perlane L Injectable GelsP040024/S0392010-01-29ReviewApproval
Paradym Vr Model 8250 & Dr Model 8550P980049/S0502010-04-07ReviewApproval
Paradym Crt-D Model 8750P060027/S0152010-04-07ReviewApproval