Barricaid® Annular Closure Device - Model Number BAR-A8-8MM (2730815-A&), Barricaid® Annular Closure Device - Model Numb
FDA premarket approval P160050/S009 · decided 2024-07-03
Approval details
- PMA number
- P160050
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Barricaid® Annular Closure Device - Model Number BAR-A8-8MM (2730815-A&), Barricaid® Annular Closure Device - Model Numb
- Generic name
- Reherniation reduction device
- Applicant
- Intrinsic Therapeutics
- Date received
- 2024-06-05
- Decision date
- 2024-07-03
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- QES
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Woburn, MA
- 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
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