Barricaid® Annular Closure Device
FDA premarket approval P160050/S008 · decided 2024-02-08
Approval details
- PMA number
- P160050
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Barricaid® Annular Closure Device
- Generic name
- Reherniation reduction device
- Applicant
- Intrinsic Therapeutics
- Date received
- 2024-01-10
- Decision date
- 2024-02-08
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- QES
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- a change to the material supplier for the nonabsorbable surgical suture sub-component used to assemble the polymer mesh component of the final device
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