Others titles
- Premarket Approval Summary Review Memos for Design Changes
- Premarket Approval Summary Review Memos
Keywords
- PMA
- Medical Device Design
- MD Changes
- MD Review
- Premarket Approval
- Premarket Approval Summary
FDA Devices Premarket Approval Summary Review Memos
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
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Description
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.
About this Dataset
Data Info
Date Created | 2013 |
---|---|
Last Modified | 2022-06-06 |
Version | 2022-06-06 |
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 |
Open for commercial use |
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 |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Device_Name | Medical Device Name | string | required : 1 |
PMA_Number | Premarket Approval Number | string | required : 1 |
Decision_Date | The Medical Device Approval Date | date | required : 1 |
Review_Memo | Review memo document's Link | string | - |
Approval_Order | Approval order document's Link | string | - |
Data Preview
Device Name | PMA Number | Decision Date | Review Memo | Approval Order |
Natrelle Silicone Filled Breast Implants | P020056/S054 | 2021-10-27 | Approval | |
Natrelle Saline Filled Breast Implants | P990074/S045 | 2021-10-27 | Approval | |
Memorygel/Memorygel Xtra Breast Implants | P030053/S062 | 2021-10-27 | Approval | |
Memoryshape Breast Implants | P060028/S041 | 2021-10-27 | Approval | |
Saline-Filled And Spectrum Breast Implants | P990075/S051 | 2021-10-27 | Approval | |
Sientra Opus Silicone Gel Breast Implants | P070004/S033 | 2021-10-27 | Approval | |
Attain Ability Mri , Plus Mri,Straight Mri Surescan; Attain Performa Mri, Straight Ans S Mri Surescan | P080006/S085 | 2016-02-01 | Review | |
Sprint Quattro Secure S Mri Surescan ; Sprint Quattro Secure Mri Surescan | P920015/S163 | 2016-02-01 | Review | |
Capsurefix Novus Mri Surescan | P930039/S140 | 2016-02-01 | Review | |
Capsurefix Mri Surescan | P090013/S202 | 2016-02-01 | Review |