Barricaid Anular Closure Device
FDA premarket approval P160050/S002 · decided 2019-05-03
Approval details
- PMA number
- P160050
- Supplement
- S002
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Barricaid Anular Closure Device
- Generic name
- Reherniation reduction device
- Applicant
- Intrinsic Therapeutics
- Date received
- 2019-03-11
- Decision date
- 2019-05-03
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- QES
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- Approval for the addition of a manufacturing site for manual lapping and the addition of an automated lapping step.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.