- Device
- Barricaid® Annular Closure Device - Model Number BAR-A8-8MM (2730815-A&), Barricaid® Annular Closure Device - Model Numb
- Applicant
- Intrinsic Therapeutics
- PMA number
- P160050
- Supplement
- S009
- Product code
- QES
- Generic name
- Reherniation reduction device
- Decision date
- 2024-07-03
- Decision code
- OK30
- Date received
- 2024-06-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a site change for the approved supplier that manufactures and assembles sub-components to the pusher instrument and an addition of a secondary supplier to the final passivation step of the bone anchor component of the final implant device