BARRICAID ANULAR CLOSURE DEVICE (ACD)
FDA premarket approval P160050 · decided 2019-02-08
Approval details
- PMA number
- P160050
- Trade name
- BARRICAID ANULAR CLOSURE DEVICE (ACD)
- Generic name
- Reherniation reduction device
- Applicant
- Intrinsic Therapeutics
- Date received
- 2016-11-10
- Decision date
- 2019-02-08
- Days to decision
- 820 days
- Decision code
- APPR
- Product code
- QES
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Woburn, MA
- 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 proc
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