← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

MIH — System, Endovascular Graft, Aortic Aneurysm Treatment

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
15
510(K)/PMA CLEARANCES
pma: 15
0
RECALL ENTRIES

Recent clearances

P210032W. L. Gore & Associates, Inc. · pma2026-07-13
P020004W. L. Gore & Associates, Inc. · pma2026-07-08
P200030W. L. Gore and Associates, Inc. · pma2026-07-08
P200045Bolton Medical, Inc. · pma2026-06-18
P190015Bolton Medical, Inc. · pma2026-06-18
P120006Endologix, LLC · pma2026-06-03
P020018Cook, Inc. · pma2026-05-21
P140016Cook Medical Incorporated · pma2026-05-21

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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