The FDA’s Center for Devices & Radiological Health released updated summary review memos detailing applications that made substantial changes to already-approved medical devices.
The 180-day supplements seek to make "a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report," according to the agency.
The table below details the latest release, posted to the FDA’s website, which includes PMA memos and approval orders related to design changes over the latest period.
|
Device Name |
PMA Number |
Decision Date |
Review Memo |
Approval Order |
|
Ddma Software |
9/12/2012 |
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|
Maximo Ii Df4 Icd, Secura Df4 Icd |
9/12/2012 |
|||
|
Unify Quadra Crt-D, Unify Quadra Assura |
8/9/2012 |
|||
|
Icd Family Of Devices & Fortify Family Of Devices |
8/9/2012 |
