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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.
 
DeviceBARRICAID ANULAR CLOSURE DEVICE (ACD)
Generic Namereherniation reduction device
Applicant
INTRINSIC THERAPEUTICS
30 commerce way
woburn, MA 01801
PMA NumberP160050
Date Received11/10/2016
Decision Date02/08/2019
Product Code QES 
Docket Number 19M-0802
Notice Date 02/19/2019
Advisory Committee Orthopedic
Clinical Trials NCT01283438
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Barricaid Anular Closure Device (ACD). The device is indicated for reducing the incidence of reherniation, and reoperation in skeletally mature patients with radiculopathy (with or without back pain) attributed to a posterior or posterolateral herniation, and confirmed by history, physical examination and imaging studies which demonstrate neural compression using MRI to treat a large anular defect (between 4-6 mm tall and between 6-10 mm wide) following a primary discectomy procedure (excision of herniated intervertebral disc) at a single level between L4 and S1.
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 
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