FDA Devices Premarket Approval Summary Review Memos

$79 / 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

2017-05-29

Version

2017-05-29

Update Frequency

Weekly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

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

Source License URL

John Snow Labs Standard License

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
Gem Iii AtP980050/S0762012-10-26http://www.accessdata.fda.gov/cdrh_docs/pdf/P980050S076M.pdfhttp://www.accessdata.fda.gov/cdrh_docs/pdf/P980050S076A.pdf
Enrythm IpgP980016/S2372010-10-19http://www.accessdata.fda.gov/cdrh_docs/pdf/P980016S237M.pdfhttp://www.accessdata.fda.gov/cdrh_docs/pdf/P980016S237A.pdf
Jewel Af IcdP980050/S0972015-10-19http://www.accessdata.fda.gov/cdrh_docs/pdf/P980050S097M.pdfhttp://www.accessdata.fda.gov/cdrh_docs/pdf/P980050S097A.pdf
Ddma SoftwareP890003/S2512012-09-12http://www.accessdata.fda.gov/cdrh_docs/pdf/P890003S251M.pdfhttp://www.accessdata.fda.gov/cdrh_docs/pdf/P890003S251A.pdf
Advisa Dr IpgP980035/S2642012-06-04http://www.accessdata.fda.gov/cdrh_docs/pdf/P980035S264M.pdfhttp://www.accessdata.fda.gov/cdrh_docs/pdf/P980035S264A.pdf
Advisa Dr IpgP980035/S1342011-04-04http://www.accessdata.fda.gov/cdrh_docs/pdf/P980035S134M.pdfhttp://www.accessdata.fda.gov/cdrh_docs/pdf/P980035S134A.pdf
Revo Mri IpgP090013/S1652015-10-19http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090013S165M.pdfhttp://www.accessdata.fda.gov/cdrh_docs/pdf9/P090013S165A.pdf
Evia Crt-P'sP070008/S0502014-05-04http://www.accessdata.fda.gov/cdrh_docs/pdf7/P070008S050M.pdfhttp://www.accessdata.fda.gov/cdrh_docs/pdf7/P070008S050A.pdf
Revo Mri IpgP090013/S1122014-02-14http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090013S112M.pdfhttp://www.accessdata.fda.gov/cdrh_docs/pdf9/P090013S112A.pdf
Revo Mri IpgP090013/S1072013-09-27http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090013S107M.pdfhttp://www.accessdata.fda.gov/cdrh_docs/pdf9/P090013S107A.pdf