BARRICAID ANULAR CLOSURE DEVICE (ACD)

Reherniation Reduction Device

FDA Premarket Approval P160050

Pre-market Approval Supplement Details

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.

DeviceBARRICAID ANULAR CLOSURE DEVICE (ACD)
Classification NameReherniation Reduction Device
Generic NameReherniation Reduction Device
ApplicantINTRINSIC THERAPEUTICS
Date Received2016-11-10
Decision Date2019-02-08
Notice Date2019-02-19
PMAP160050
SupplementS
Product CodeQES
Docket Number19M-0802
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address INTRINSIC THERAPEUTICS 30 Commerce Way woburn, MA 01801
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P160050Original Filing
S006 2020-04-22 Normal 180 Day Track No User Fee
S005 2020-04-16 Normal 180 Day Track No User Fee
S004
S003 2019-03-19 Real-time Process
S002 2019-03-11 135 Review Track For 30-day Notice
S001 2019-03-08 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
M906BARA810MM0 P160050 000
M906BARA88MM0 P160050 000
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