Barricaid Anular Closure Device
FDA premarket approval P160050/S001 · decided 2019-05-07
Approval details
- PMA number
- P160050
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Barricaid Anular Closure Device
- Generic name
- Reherniation reduction device
- Applicant
- Intrinsic Therapeutics
- Date received
- 2019-03-08
- Decision date
- 2019-05-07
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- QES
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- Approval of two protocols for the post-approval study (PAS) protocol.
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