- Device
- Barricaid® Annular Closure Device
- Applicant
- Intrinsic Therapeutics
- PMA number
- P160050
- Supplement
- S012
- Product code
- QES
- Generic name
- Reherniation reduction device
- Decision date
- 2026-03-24
- Decision code
- OK30
- Date received
- 2026-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for an alternate manufacturing process and new supplier affecting critical components of the Barricaid implant device/delivery system, specifically the 8mm Delivery Sheath