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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEmbrace(TM) Hydrogel Embolic System
Generic NameEmbolization Agent, Vascular
ApplicantInstylla, Inc.
201 Burlington Rd.
North Bldg.
Bedford, MA 01730
PMA NumberP250003
Supplement NumberS008
Date Received04/28/2026
Decision Date10/23/2026
Product Code QVG 
Advisory Committee Cardiovascular
Clinical TrialsNCT05364502
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
This device is indicated for embolization of hypervascular tumors in peripheral arteries = 5mm and peripheral arterial bleeds in vessels = 6mm.
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