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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEmbrace(TM) Hydrogel Embolic System
Generic NameEmbolization Agent, Vascular
ApplicantInstylla, Inc.
201 Burlington Rd.
North Bldg.
Bedford, MA 01730
PMA NumberP250003
Date Received02/06/2025
Decision Date08/05/2025
Product Code QVG 
Advisory Committee Cardiovascular
Clinical TrialsNCT04523350
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Embrace Hydrogel Embolic System (HES) is indicated for embolization of hypervascular tumors in peripheral arteries ? 5mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 S005 S006 S009 
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